Trial Outcomes & Findings for Mesothelin-Targeted Immunotoxin LMB-100 Alone or in Combination With Nab-Paclitaxel in People With Previously Treated Metastatic and/or Locally Advanced Pancreatic Ductal Adenocarcinoma and Mesothelin Expressing Solid Tumors (NCT NCT02810418)
NCT ID: NCT02810418
Last Updated: 2022-03-15
Results Overview
OR is defined as partial responses + complete response in participants in the phase 2 Arm A portion of the study assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete Response is a disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Approximately 6 weeks after the start of treatment and continuing every 6 weeks until progression or start of a new treatment, up to 1 year
Results posted on
2022-03-15
Participant Flow
Participant milestones
| Measure |
Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100
Arm A1, DL1, Ph I Short Infusion 100µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel
LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel
LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
|---|---|---|---|---|---|---|---|
|
Arm A Dose Escalation
STARTED
|
6
|
8
|
0
|
0
|
0
|
0
|
0
|
|
Arm A Dose Escalation
COMPLETED
|
4
|
7
|
0
|
0
|
0
|
0
|
0
|
|
Arm A Dose Escalation
NOT COMPLETED
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion
STARTED
|
0
|
8
|
6
|
0
|
0
|
0
|
0
|
|
Dose Expansion
COMPLETED
|
0
|
7
|
3
|
0
|
0
|
0
|
0
|
|
Dose Expansion
NOT COMPLETED
|
0
|
1
|
3
|
0
|
0
|
0
|
0
|
|
Arm B Dose Escalation
STARTED
|
0
|
0
|
0
|
6
|
3
|
6
|
0
|
|
Arm B Dose Escalation
COMPLETED
|
0
|
0
|
0
|
6
|
2
|
4
|
0
|
|
Arm B Dose Escalation
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
|
Arm B Combination Therapy
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
|
Arm B Combination Therapy
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
|
Arm B Combination Therapy
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100
Arm A1, DL1, Ph I Short Infusion 100µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel
LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel
LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
|---|---|---|---|---|---|---|---|
|
Arm A Dose Escalation
Adverse Event
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Dose Expansion
Adverse Event
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Dose Expansion
Physician Decision
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Arm B Dose Escalation
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
Baseline Characteristics
Mesothelin-Targeted Immunotoxin LMB-100 Alone or in Combination With Nab-Paclitaxel in People With Previously Treated Metastatic and/or Locally Advanced Pancreatic Ductal Adenocarcinoma and Mesothelin Expressing Solid Tumors
Baseline characteristics by cohort
| Measure |
Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100
n=6 Participants
Arm A1, DL1, Ph I Short Infusion 100µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel
LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=8 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel
LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel
LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=6 Participants
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=3 Participants
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
n=6 Participants
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
n=5 Participants
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
25 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
15 Participants
n=24 Participants
|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
69.9 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 12.5 • n=4 Participants
|
59.2 years
STANDARD_DEVIATION 12.3 • n=21 Participants
|
62.8 years
STANDARD_DEVIATION 7.9 • n=10 Participants
|
66.8 years
STANDARD_DEVIATION 10.4 • n=115 Participants
|
61.0 years
STANDARD_DEVIATION 10.6 • n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
18 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
22 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
36 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
4 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
32 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
3 participants
n=21 Participants
|
6 participants
n=10 Participants
|
5 participants
n=115 Participants
|
40 participants
n=24 Participants
|
|
Number of Participants with Prior Therapies
Whipple
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
20 Participants
n=24 Participants
|
|
Number of Participants with Prior Therapies
Radiation
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
26 Participants
n=24 Participants
|
|
Number of Participants with Prior Therapies
Prior nab-paclitaxel
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
20 Participants
n=24 Participants
|
|
Number of Participants with Sites of Disease
Liver
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
24 Participants
n=24 Participants
|
|
Number of Participants with Sites of Disease
Lung
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
23 Participants
n=24 Participants
|
|
Number of Participants with Sites of Disease
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
25 Participants
n=24 Participants
|
|
Number of Participants with Sites of Disease
Ascites
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
8 Participants
n=24 Participants
|
|
Participants Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
0
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
14 Participants
n=24 Participants
|
|
Participants Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
1
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
24 Participants
n=24 Participants
|
|
Participants Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Participants Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
|
Baseline CA 19-9
Patient 1
|
404.7 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
404.7 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 2
|
10650 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
10650 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 3
|
248800 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
248800 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 4
|
27.8 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
27.8 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 5
|
7081 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
7081 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 6
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
123 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
123 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 7
|
1277 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
1277 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 8
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
94210 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
94210 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 9
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
1500 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
1500 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 10
|
0 Unit/mL
n=5 Participants
|
10106 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
10106 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 11
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
13.2 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
13.2 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 12
|
0 Unit/mL
n=5 Participants
|
25180 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
25180 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 13
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
14.8 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
14.8 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 14
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
911.3 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
911.3 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 15
|
0 Unit/mL
n=5 Participants
|
88.4 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
88.4 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 16
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
284.7 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
284.7 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 17
|
0 Unit/mL
n=5 Participants
|
302.6 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
302.6 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 18
|
0 Unit/mL
n=5 Participants
|
4206 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
4206 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 19
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
93.7 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
93.7 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 20
|
0 Unit/mL
n=5 Participants
|
4482 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
4482 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 21
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
142.9 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
142.9 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 22
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
446.6 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
446.6 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 23
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
389.5 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
389.5 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 24
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
156.8 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
156.8 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 25
|
0 Unit/mL
n=5 Participants
|
13348 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
13348 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 26
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
9254 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
9254 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 27
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
138.3 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
138.3 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 28
|
0 Unit/mL
n=5 Participants
|
0.6 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
0.6 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 29
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
9571 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
9571 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 30
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
2077 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
2077 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 31
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
3424 Unit/mL
n=115 Participants
|
3424 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 32
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
9326 Unit/mL
n=115 Participants
|
9326 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 33
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
760 Unit/mL
n=115 Participants
|
760 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 34
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
3297 Unit/mL
n=115 Participants
|
3297 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 35
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
6345 Unit/mL
n=115 Participants
|
6345 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 36
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
2966 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
2966 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 37
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
99.8 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
99.8 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 38
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
1340 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
1340 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 39
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
31440 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
31440 Unit/mL
n=24 Participants
|
|
Baseline CA 19-9
Patient 40
|
0 Unit/mL
n=5 Participants
|
0 Unit/mL
n=7 Participants
|
3857 Unit/mL
n=5 Participants
|
0 Unit/mL
n=4 Participants
|
0 Unit/mL
n=21 Participants
|
0 Unit/mL
n=10 Participants
|
0 Unit/mL
n=115 Participants
|
3857 Unit/mL
n=24 Participants
|
PRIMARY outcome
Timeframe: Approximately 6 weeks after the start of treatment and continuing every 6 weeks until progression or start of a new treatment, up to 1 yearOR is defined as partial responses + complete response in participants in the phase 2 Arm A portion of the study assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete Response is a disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=14 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Objective Response (OR) (Partial Responses + Complete Responses) in Phase 2 Subjects of Short Infusion LMB-100+ Nab-paclitaxel
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 21 days after LMB-100 is administered (end of cycle 1)MTD is defined as the highest dose tolerated without exceeding a pre-set number of adverse events in Phase 1, Arm A.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=14 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Short Infusion LMB-100 + Nab Paclitaxel
|
65 µg/kg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 21 days after LMB-100 is administered (end of cycle 1)Population: Arm B2, Phase I, 24-hour continuous infusion combination therapy is not reported here because MTD was only assessed in the Phase I, Arm B single agent lead-in Arm/Groups. Please note: Dose 100 (µg/kg/day), for duration (24 Hours), schedule Days 1 \& 4, preceded by a 40 mcg/kg loading dose over 30 minutes, was determined to be the preferred schedule.
MTD is defined as the highest dose tolerated without exceeding a pre-set number of adverse events in Phase 1, 1 Arm B, single agent lead-in
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=15 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Continuous Infusion LMB-100
|
100 Dose (µg/kg)
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Time from treatment initiation to disease progression or death, an average of 1 year.Population: It was specified in the protocol that patients enrolled in Arm A1 who received the maximum tolerated dose (MTD) should be included for PFS endpoint analysis of Arm A2 data. Therefore, 8 (Arm A1, DL-1) + 6 (Arm A2) = 14 patients were included in the Arm 2 PFS analysis.
PFS is the average time from treatment initiation to disease progression or death. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. And the appearance of one or more new lesions.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=8 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=14 Participants
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=3 Participants
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=6 Participants
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
n=6 Participants
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
n=5 Participants
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS)
|
NA Months
We are unable to calculate PFS of the regimen in any arm because multiple participants with stable disease immediately went on to receive other treatments following their planned 2 cycles of LMB-100.
|
NA Months
We are unable to calculate PFS of the regimen in any arm because multiple participants with stable disease immediately went on to receive other treatments following their planned 2 cycles of LMB-100.
|
NA Months
We are unable to calculate PFS of the regimen in any arm because multiple participants with stable disease immediately went on to receive other treatments following their planned 2 cycles of LMB-100.
|
NA Months
We are unable to calculate PFS of the regimen in any arm because multiple participants with stable disease immediately went on to receive other treatments following their planned 2 cycles of LMB-100.
|
NA Months
We are unable to calculate PFS of the regimen in any arm because multiple participants with stable disease immediately went on to receive other treatments following their planned 2 cycles of LMB-100.
|
NA Months
We are unable to calculate PFS of the regimen in any arm because multiple participants with stable disease immediately went on to receive other treatments following their planned 2 cycles of LMB-100.
|
NA Months
We are unable to calculate PFS of the regimen in any arm because multiple participants with stable disease immediately went on to receive other treatments following their planned 2 cycles of LMB-100.
|
—
|
—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from treatment initiation to death, up to 1-2 years.Population: Arm/Groups A1 and B1 are not separated per Arm/Group because the breakdown by individual treatment group within each arm results in numbers that are so small that the data becomes virtually useless. Patients enrolled in A1 who were treated at the maximum tolerated dose (MTD) and meet the eligibility requirement for A2 are also counted toward the A2 endpoints as per protocol.
OS is the average time from treatment initiation to death.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=14 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=14 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=15 Participants
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=5 Participants
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
202 Days
Standard Deviation 332
|
160 Days
Standard Deviation 196
|
89 Days
Standard Deviation 124
|
167 Days
Standard Deviation 348
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: up to 3 monthsPopulation: It was planned that this outcome measure would be reported by Arm and not by individual dose levels within each arm. Pts enrolled in A1 who were treated at the max.tolerated dose and meet the eligibility requirement for A2 are also counted toward the A2 endpoints as per protocol. We are unable to calculate DCR at 4 mos because many pts with stable disease immediately went on to receive other therapies following completion of scheduled 2-3 cycles of LMB-100. Therefore,we are reporting DCR at EOT.
DCR is the proportion of participants with stable disease, partial response or complete response at end of treatment. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=14 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=14 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=15 Participants
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=5 Participants
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)
Partial Response
|
0.07 Proportion of participants
|
0.07 Proportion of participants
|
0 Proportion of participants
|
0 Proportion of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)
Complete Response
|
0 Proportion of participants
|
0 Proportion of participants
|
0 Proportion of participants
|
0 Proportion of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)
Progressive Disease
|
0.21 Proportion of participants
|
0.36 Proportion of participants
|
0.60 Proportion of participants
|
2 Proportion of participants
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)
Stable Disease
|
0.71 Proportion of participants
|
0.5 Proportion of participants
|
0.27 Proportion of participants
|
0.4 Proportion of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Proportion of Participants Disease Control Rate (DCR) at End of Treatment (EOT)
Not Evaluable
|
0 Proportion of participants
|
0.07 Proportion of participants
|
0.13 Proportion of participants
|
1 Proportion of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 weeks after the start of treatment and continuing every 6 weeks until progression or start of a new treatment up to 1 year.OR is defined as partial response + complete response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete Response is a disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=8 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With an Objective Response (OR) (Partial Responses + Complete Responses) in Phase 1 Arm A1
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Approximately 6 weeks after the start of treatment and continuing every 6 weeks until progression or start of a new treatment up to 1 year.OR is defined as partial responses + complete response in participants in the phase 1 Arm B portion of the study assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete Response is a disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=3 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With an Objective Response (OR) (Partial Response + Complete Response) in Phase 1, Arm B
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approx. 11 mos, 8 days for A1DL1; 20 mos, 9 days for A1DL-1; 10 mos, 17 days for A2; 2 mos, 16 days for B1DL1; 14 mos, 30 days for B1DL2; 5 mos, 1 day for B2; and 4 mos, 15 days for B1DL3R.Population: No B2 grade 1, 3, and 4; B1 DL1 grade 1, 3, and 4; B1 DL2 grade 1; and B1 DL3R grade 1, 3, and 4 adverse events.
Grade 1-4 adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 observed in subjects with pancreatic cancer. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe or medically significant. Grade 4 is life-threatening consequences.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=6 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=8 Participants
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=8 Participants
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
n=8 Participants
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
n=8 Participants
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
n=6 Participants
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
n=6 Participants
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
n=6 Participants
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
n=6 Participants
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
n=6 Participants
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
n=6 Participants
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
n=6 Participants
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
n=3 Participants
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
n=6 Participants
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
n=5 Participants
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events Attributed to LMB-100
Pericardial effusion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Pleural effusion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Pleuritic pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Proteinuria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Acute kidney injury
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Allergic reaction
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Anemia
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Anorexia
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Ascites
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Atrial fibrillation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Creatinine increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Decreased urine output
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Dehydration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Dizziness
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Dyspnea
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Edema
|
2 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Electrolyte disturbances
|
1 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Elevated LFT's
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Fatigue
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Generalized pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
GI disturbances
|
2 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Hypoalbuminemia
|
4 Participants
|
6 Participants
|
0 Participants
|
7 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Hypocalcemia
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Hyponatremia
|
4 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Hypophosphatemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Hypotension
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Hypoxia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Infusion-related reactions
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Lymphocyte count decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Nausea and vomiting
|
2 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Pulmonary edema
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Rash and pruritis
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Tachycardia
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Ventricular dysfunction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Weight gain
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Cough
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Fever
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Myalgia
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events Attributed to LMB-100
Chills
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approx. 11 mos, 8 days for A1DL1; 20 mos, 9 days for A1DL-1; 10 mos, 17 days for A2; 2 mos, 16 days for B1DL1; 14 mos, 30 days for B1DL2; 5 mos, 1 day for B2; and 4 mos, 15 days for B1DL3R.Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=8 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=6 Participants
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=3 Participants
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
n=6 Participants
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
n=5 Participants
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).
|
6 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: First 28 days following infusion of LMB-100 on Cycle 1, Day 1 through the duration of the study treatment up to 1 year.Population: Arm A2 Phase 2 is not shown because it is not applicable due to dose expansion.
A DLT is defined per protocol as events attributed to LMB-100 and occurring during the DLT period such as hematological toxicities: Grade 4 neutropenia, Grade 3 and 4 febrile neutropenia, Grade 4 thrombocytopenia, and Grade 3 thrombocytopenia associated with bleeding episodes. Grade ≥3 non-hematological toxicity with the exception of: Grade 3 nausea and vomiting without appropriate treatment, Grade 3 diarrhea lasting ≤2 days with no fever or dehydration, and isolated Grade 3 fever. Grade ≥4 non-hematological toxicity: infusion related reactions, and any other drug related toxicity qualified as a DLT per the discretion of the principal investigator.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=8 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=3 Participants
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=6 Participants
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
n=5 Participants
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Grade 3 Edema
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Grade 3 Fatigue
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Grade 3 Hypotension
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Grade 3 Myalgia
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Grade 3 Urine output decreased
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Grade 3 proteinuria
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
Grade 1 creatinine increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1 Day 1.Population: Extended serum drug concentrations are available for all participants during Cycle 1. During Cycle 2, these bloods were not drawn (per protocol) after the first few participants on study, therefore elimination rate and AUC could only be calculated for Cycle 1 in most patients. Results from all participants receiving 65 mcg/kg short infusion were combined for the pharmacokinetic analysis as all received the same dose of LMB-100.
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0). It is used to characterize drug absorption.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=14 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration vs. Time Curve Extrapolated to Infinity (AUCinf)
|
2,550 h*ng/mL
Standard Deviation 38.2
|
1,409 h*ng/mL
Standard Deviation 47.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1 Day 1.Population: Extended serum drug concentrations are available for all participants during Cycle 1. During Cycle 2, these bloods were not drawn (per protocol) after the first few participants on study, therefore elimination rate and AUC could only be calculated for Cycle 1 in most patients. Results from all participants receiving 65 mcg/kg short infusion were combined for the pharmacokinetic analysis as all received the same dose of LMB-100.
The AUC is a measure of the serum concentration of the drug dose over time. It is used to characterize drug absorption.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=14 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf)/D (Dose)
|
415 H*ng/mL/mg
Standard Deviation 56.5
|
315 H*ng/mL/mg
Standard Deviation 45.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For Arms B1 & B2: Pre-dose, end of loading dose, 2 and 6 hours after start of continuous infusion, end of infusion (EOI) and 2 hrs after EOI during Cycle 1 Day 1.Population: Extended serum drug concentrations are avail. for all participants during C1. During C2, these bloods were not drawn (per protocol) after the first few participants on study, therefore elimination rate \& AUC could only be calculated for C1 in most pts. AUClast is reported for Arms B1 and B2 as the measurements taken do not permit calculation of AUCinf.
The AUC is a measure of the serum concentration of the drug dose over time. It is used to characterize drug absorption
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=3 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=6 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=5 Participants
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration Versus Time Curve Extrapolated to Last Measurement (AUClast)/D
|
519 h*ng/ml/mg
Standard Deviation 604
|
229 h*ng/ml/mg
Standard Deviation 71
|
233 h*ng/ml/mg
Standard Deviation 64
|
288 h*ng/ml/mg
Standard Deviation 184
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For Arms B1 & B2: Pre-dose, end of loading dose, 2 and 6 hours after start of continuous infusion, end of infusion (EOI) and 2 hrs after EOI during Cycle 1.Population: Extended serum drug concentrations are avail. for all participants during C1. During C2, these bloods were not drawn (per protocol) after the first few participants on study, therefore elimination rate \&AUC could only be calculated for C1 in most pts. AUClast is reported for Arms B1 and B2 as the measurements taken do not permit calculation of AUCinf.
Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated to last measurement. It is used to characterize drug absorption.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=3 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=6 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=5 Participants
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time Curve Extrapolated to Last Measurement (AUClast) for LMB-100
|
2671 h*ng/ml
Standard Deviation 2778
|
4148 h*ng/ml
Standard Deviation 1746
|
2508 h*ng/ml
Standard Deviation 388
|
2417 h*ng/ml
Standard Deviation 1006
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1 Day 1.Population: LMB100 plasma conc. avail. for 20 pts on Arms A1/A2. Extended plasma drug conc. avail. for all pts during C1. During C2, these bloods were not drawn (per protocol) after1st few pts on study; elimination rate \& T1/2 could only be calc. for C1 in most pts. Results from all pts w/65 mcg/kg short infusion were combined for the pharmacokinetic analysis (all rec'd same dose LMB-100). Arms B1/B2 calc. of T1/2 was not planned \& plasma sample time points were inappropriate for computing this measure.
The CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=14 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Total Clearance (CL) of LMB-100
|
2.97 L/h
Standard Deviation 44.3
|
4.98 L/h
Standard Deviation 116
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1, Day 1.Population: LMB100 plasma conc. avail. for 20 pts on Arms A1/A2. Extended plasma drug conc. avail. for all pts during C1. During C2, these bloods were not drawn (per protocol) after1st few pts on study; elimination rate \& T1/2 could only be calc. for C1 in most pts. Results from all pts w/65 mcg/kg short infusion were combined for the pharmacokinetic analysis (all rec'd same dose LMB-100). Arms B1/B2 calc. of T1/2 was not planned \& plasma sample time points were inappropriate for computing this measure.
Plasma decay half-life is the time measured for the plasma concentration of the drug to decrease by one half.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=14 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Half-Life (T1/2) of LMB-100
|
1.25 hour(h)
Standard Deviation 53.9
|
0.99 hour(h)
Standard Deviation 12.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1, Day 1.Population: LMB100 plasma conc. avail. for 20 pts on Arms A1/A2. Extended plasma drug conc. avail. for all pts during C1. During C2, these bloods were not drawn (per protocol) after1st few pts on study; elimination rate \& T1/2 could only be calc. for C1 in most pts. Results from all pts w/65 mcg/kg short infusion were combined for the pharmacokinetic analysis (all rec'd same dose LMB-100). Arms B1/B2 calc. of T1/2 was not planned \& plasma sample time points were inappropriate for computing this measure.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=14 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Volume of Distribution (Vd) of LMB-100
|
4.91 L
Standard Deviation 20.5
|
7.48 L
Standard Deviation 106
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1 Day. Pre-dose and end of infusion (EOI) during Cycle 2 Day 1.Population: LMB-100 peak plasma concentrations were available for all patients treated on study. Results from all participants receiving 65 mcg/kg short infusion (Arms A1 \& A2) were combined for the pharmacokinetic analysis as all received the same dose of LMB-100.
The maximum observed analyte concentration in serum was reported.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=14 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm A1 and Arm A2
Cycle 1 Day 1
|
1,282 ng/mL
Standard Deviation 14.9
|
858.9 ng/mL
Standard Deviation 43.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm A1 and Arm A2
Cycle 2 Day 1
|
1,306 ng/mL
|
748 ng/mL
Standard Deviation 58.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For Arms B1 & B2: Pre-dose, end of loading dose, 2 and 6 hours after start of continuous infusion, end of infusion (EOI) and 2 hrs after EOI during Cycle 1 Day 1. Pre-dose, end of loading dose and EOI during Cycle 2 Day 1.Population: LMB-100 peak plasma concentrations were available for all patients treated on study. The Cmax reported for Arms B1 DL2 and DL3R and for Arm B2 occurred at end of the loading dose. Only non-zero values are reported for two participants in Cycle 2.
The maximum observed analyte concentration in serum was reported.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=3 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=6 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=5 Participants
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2
Cycle 1 Day 1
|
1124 ng/mL
Standard Deviation 1892
|
488 ng/mL
Standard Deviation 270
|
485 ng/mL
Standard Deviation 154
|
307 ng/mL
Standard Deviation 163
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed (Peak) Plasma Concentration (Cmax) of LMB-100 in Arm B1 and Arm B2
Cycle 2 Day 1
|
—
|
371 ng/mL
|
—
|
195 ng/mL
Standard Deviation 248
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For Arms A1 & A2: Pre-dose, end of infusion (EOI), 1, 2 and 4 hours after EOI during Cycle 1 Day 1. Pre-dose and end of infusion (EOI) during Cycle 2 Day 1.Population: LMB-100 peak plasma concentrations were available for all patients treated on study. Results from all participants receiving 65 mcg/kg short infusion (Arms A1 \& A2) were combined for the pharmacokinetic analysis as all received the same dose of LMB-100.
The maximum observed analyte concentration of dose was reported.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=14 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm A1 and Arm A2
Cycle 1 Day 1
|
197 ng/mL/mg
Standard Deviation 18.5
|
188 ng/mL/mg
Standard Deviation 77.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm A1 and Arm A2
Cycle 2 Day 1
|
181 ng/mL/mg
|
158 ng/mL/mg
Standard Deviation 51.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: For Arms B1 & B2: Pre-dose, end of loading dose, 2 and 6 hours after start of continuous infusion, end of infusion (EOI) and 2 hrs after EOI during Cycle 1 Day 1. Pre-dose, end of loading dose and EOI during Cycle 2 Day 1.Population: LMB-100 peak plasma concentrations were available for all patients treated on study. The Cmax reported for Arms B1 DL2 and DL3R and for Arm B2 occurred at end of the loading dose. Only non-zero values are reported for two participants in Cycle 2.
The maximum observed analyte concentration in serum was reported.
Outcome measures
| Measure |
All Participants in Arm A1 DL-1 and Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=3 Participants
All participants in Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100 Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles AND Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=6 Participants
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 Participants
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=5 Participants
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg LMB-100
(continuous infusion LMB-100 as a single agent): Administered intravenously (IV) for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles
|
Arm A2, Phase 2 Grade 2
Grade 2 moderate adverse events.
|
Arm A2, Phase 2 Grade 1
Grade 1 mild adverse events.
|
Arm A2, Phase 2 Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm A2, Phase 2 Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 3
Grade 3 severe or medically significant adverse events.
|
Arm B1, Dose Level 2 Phase I Grade 4
Grade 4 life-threatening adverse events.
|
Arm B1, Dose Level 1 Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B1, Dose Level 3R Phase I Grade 2
Grade 2 moderate adverse events.
|
Arm B2 Phase I Grade 2
Grade 2 moderate adverse events.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm B1 and Arm B2
Cycle 1 Day 1
|
235 ng/mL
Standard Deviation 398
|
26.3 ng/mL
Standard Deviation 12.1
|
45.1 ng/mL
Standard Deviation 18.5
|
34.5 ng/mL
Standard Deviation 19.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Observed (Peak) Plasma Concentration (Cmax)/D (Dose) of LMB-100 in Arm B1 and Arm B2
Cycle 2 Day 1
|
—
|
20.8 ng/mL
|
—
|
10.5 ng/mL
Standard Deviation 5.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100
Serious events: 3 serious events
Other events: 6 other events
Deaths: 5 deaths
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
Serious events: 4 serious events
Other events: 8 other events
Deaths: 8 deaths
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
Serious events: 1 serious events
Other events: 6 other events
Deaths: 5 deaths
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in 10
Serious events: 2 serious events
Other events: 6 other events
Deaths: 6 deaths
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Arm B1,Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
Serious events: 2 serious events
Other events: 6 other events
Deaths: 6 deaths
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100
n=6 participants at risk
Arm A1, DL1, Ph I Short Infusion 100µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel
LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=8 participants at risk
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel
LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 participants at risk
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel
LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in 10
n=6 participants at risk
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=3 participants at risk
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1,Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
n=6 participants at risk
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
n=5 participants at risk
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Abdominal infection
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
General disorders
Chills
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Gastrointestinal disorders
Colonic perforation
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
General disorders
Death NOS
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
General disorders
Localized edema
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, death
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, pancreatic cancer
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, died at home
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Infections and infestations
Peritoneal infection
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
Other adverse events
| Measure |
Arm A1, Dose Level 1, Phase I Short Infusion 100µg/kg LMB-100
n=6 participants at risk
Arm A1, DL1, Ph I Short Infusion 100µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel
LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A1, Dose Level-1, Phase I Short Infusion 65µg/kg LMB-100
n=8 participants at risk
Arm A1, DL-1, Ph I Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel
LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm A2, Phase 2 Short Infusion 65µg/kg LMB-100
n=6 participants at risk
Arm A2, Ph 2 Short Infusion 65µg/kg LMB-100 +125mg/m\^2 nab-paclitaxel
LMB-100 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on days 1, and 8 of each 21 day cycle for a maximum of 2 cycles
|
Arm B1, Dose Level 2, Phase I 48-hr Continuous Infusion Single Agent Lead-in 10
n=6 participants at risk
Arm B1, DL2, 48-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered intravenously (IV)for 48 hours continuously on the first 1 - 2 days of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B1, Dose Level 1, Phase I 48-hr Continuous Infusion Single Agent Lead-in
n=3 participants at risk
Arm B1, DL1, 48-hr Continuous Infusion Single Agent Lead-in 65µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 48 hours continuously on the first 1 - 4 days of each 21 day cycle for a maximum of 2 cycles
|
Arm B1,Dose Level 3R, Phase I 24-hr Continuous Infusion Single Agent Lead-in
n=6 participants at risk
Arm B1, DL3R, 24-hr Continuous Infusion Single Agent Lead-in 100µg/kg/day LMB-100 (continuous infusion LMB-100 as a single agent): Administered IV for 24 hours continuously starting on days 1 and 4 of each 21 day cycle for a maximum of 2 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
|
Arm B2, Phase I 24-hr Continuous Infusion Combo Therapy 100µg/kg
n=5 participants at risk
Arm B2, 24-hr Continuous Infusion Combo Therapy 100µg/kg/day LMB-100+125mg/m\^ nab-paclitaxel Arms B2 (continuous infusion LMB-100): Administered intravenously (IV) for 24 hours continuously starting on day 1 of each 14 day cycle for a maximum of 3 cycles. A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.;125mg/m\^2 Nab-Paclitaxel: Administered intravenously (IV) on day 1of each 14 day cycle for a maximum of 3 cycles.
|
|---|---|---|---|---|---|---|---|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
50.0%
4/8 • Number of events 4 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
50.0%
3/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
33.3%
2/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
66.7%
2/3 • Number of events 4 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
33.3%
2/6 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
50.0%
3/6 • Number of events 5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
25.0%
2/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, tachypnea intermittent
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
33.3%
1/3 • Number of events 5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Cardiac disorders
Sinus tachycardia
|
66.7%
4/6 • Number of events 7 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
37.5%
3/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
40.0%
2/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, buttock excoriation
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Vascular disorders
Thromboembolic event
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
25.0%
2/8 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Renal and urinary disorders
Urine output decreased
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
12.5%
1/8 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
25.0%
2/8 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
33.3%
2/6 • Number of events 4 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Investigations
Weight gain
|
33.3%
2/6 • Number of events 6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
50.0%
4/8 • Number of events 6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
50.0%
3/6 • Number of events 10 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
33.3%
2/6 • Number of events 8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
33.3%
1/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
40.0%
2/5 • Number of events 4 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/5 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
|
Investigations
White blood cell decreased
|
66.7%
4/6 • Number of events 12 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
75.0%
6/8 • Number of events 18 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
66.7%
4/6 • Number of events 7 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/6 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
16.7%
1/6 • Number of events 2 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
60.0%
3/5 • Number of events 8 • Date treatment consent signed to date off study, approximately 11 months, 8 days for A1DL1; 20 months, 9 days A1DL-1; 10 months, 17 days for A2; 2 months, 16 days for B1DL1; 14 months, 30 days for B1DL2; 5 months, 1 day for B2; and 4 months, 15 days for B1DL3R.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place