Trial Outcomes & Findings for Anti-Mesothelin Immunotoxin LMB-100 Followed by Pembrolizumab in Malignant Mesothelioma (NCT NCT03644550)
NCT ID: NCT03644550
Last Updated: 2021-12-02
Results Overview
Number of participants who received at least 1 cycle of study therapy and who had their disease reevaluated that experienced a partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST criteria. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. 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
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Every 6 weeks until disease progression, an average of 3.1 months
Results posted on
2021-12-02
Participant Flow
Participant milestones
| Measure |
1/LMB- 100+Pembrolizumab
LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.
LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.
LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).
Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
1/LMB- 100+Pembrolizumab
LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.
LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.
LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).
Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Progressive disease
|
15
|
Baseline Characteristics
Anti-Mesothelin Immunotoxin LMB-100 Followed by Pembrolizumab in Malignant Mesothelioma
Baseline characteristics by cohort
| Measure |
1/LMB- 100+Pembrolizumab
n=18 Participants
LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.
LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.
LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial)..
Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
61.62 years
STANDARD_DEVIATION 12.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every 6 weeks until disease progression, an average of 3.1 monthsPopulation: 17/18 participants were evaluable for this outcome measure.
Number of participants who received at least 1 cycle of study therapy and who had their disease reevaluated that experienced a partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST criteria. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. 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 |
1/LMB- 100+Pembrolizumab
n=17 Participants
LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.
LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.
LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).
Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.
|
|---|---|
|
Number of Participants With an Objective Response (Partial Response + Complete Response)
Partial Response
|
3 Participants
|
|
Number of Participants With an Objective Response (Partial Response + Complete Response)
Complete Response
|
0 Participants
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 22 months and 29 days.Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). 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 |
1/LMB- 100+Pembrolizumab
n=18 Participants
LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.
LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.
LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).
Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.
|
|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0).
|
18 Participants
|
SECONDARY outcome
Timeframe: Time from start of treatment to time of progression (on or after pembrolizumab) or death, whichever occurs first, an average of 6.5 monthsProgression free survival (PFS) is defined as the duration of time from start of treatment to time of progression (on or after pembrolizumab) or death, whichever occurs first. 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.
Outcome measures
| Measure |
1/LMB- 100+Pembrolizumab
n=18 Participants
LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.
LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.
LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).
Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.
|
|---|---|
|
Progression Free Survival (PFS)
|
7.1 Months
Interval 4.3 to 8.4
|
SECONDARY outcome
Timeframe: Time between the first day of treatment to the day of death, an average of 17 monthsOverall survival is the time between the first day of treatment to the day of death.
Outcome measures
| Measure |
1/LMB- 100+Pembrolizumab
n=18 Participants
LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.
LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.
LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).
Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.
|
|---|---|
|
Overall Survival (OS)
|
17.1 Months
Interval 10.2 to 27.5
|
SECONDARY outcome
Timeframe: Time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, an average of 3.1 monthsThe duration of overall response is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented. Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is defined as disappearance of all target lesions with no evidence of tumor elsewhere. Partial Response (PR) is defined as at least a 30% decrease in the total tumor measurement.
Outcome measures
| Measure |
1/LMB- 100+Pembrolizumab
n=18 Participants
LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.
LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.
LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).
Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.
|
|---|---|
|
Duration of Overall Response (DOR)
|
3.1 Months
Interval 2.8 to 11.7
|
SECONDARY outcome
Timeframe: An average of 3.1 months.Population: 17/18 participants were evaluable for this outcome measure.
Percentage of participants who received at least 1 cycle of study therapy and who had their disease reevaluated that experienced a partial or complete response per the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST criteria. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. 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 |
1/LMB- 100+Pembrolizumab
n=17 Participants
LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.
LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.
LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).
Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.
|
|---|---|
|
Percentage of Participants With an Overall Response
|
17.6 percentage of participants
|
Adverse Events
1/LMB- 100+Pembrolizumab
Serious events: 14 serious events
Other events: 18 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
1/LMB- 100+Pembrolizumab
n=18 participants at risk
LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.
LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.
LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).
Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
3/18 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
CPK increased
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Vascular disorders
Capillary leak syndrome
|
11.1%
2/18 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Colitis
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Infections and infestations
Lung infection
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, death
|
38.9%
7/18 • Number of events 7 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
11.1%
2/18 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
5.6%
1/18 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
Thyroid stimulating hormone increased
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
Other adverse events
| Measure |
1/LMB- 100+Pembrolizumab
n=18 participants at risk
LMB-100 administered in cycles 1 and 2 + pembrolizumab administered in subsequent cycles.
LMB-100 140mcg/kg Intravenous infusion (IVI), Days 1, 3, 5 in cycles 1, 2. Pembrolizumab 200mg IVI, every (Q) subsequent cycle on Day 1.
LMB-100: Given intravenous (IV) at recommended phase 2 dose (RP2D) on days 1, 3 and 5 of two (2) 21 day cycles (i.e. RP2D was determined in a previous phase I trial).
Pembrolizumab: Given intravenous (IV) at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
38.9%
7/18 • Number of events 9 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
38.9%
7/18 • Number of events 14 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
Alanine aminotransferase increased
|
77.8%
14/18 • Number of events 21 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
6/18 • Number of events 14 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Blood and lymphatic system disorders
Anemia
|
94.4%
17/18 • Number of events 109 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Anorexia
|
38.9%
7/18 • Number of events 9 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Psychiatric disorders
Anxiety
|
11.1%
2/18 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
2/18 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.6%
1/18 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
Aspartate aminotransferase increased
|
72.2%
13/18 • Number of events 24 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
4/18 • Number of events 7 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Infections and infestations
Bacteremia
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Bloating
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
Blood lactate dehydrogenase increased
|
11.1%
2/18 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
CPK increased
|
11.1%
2/18 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Vascular disorders
Capillary leak syndrome
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
Cardiac troponin I increased
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
General disorders
Chills
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Psychiatric disorders
Confusion
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
4/18 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
61.1%
11/18 • Number of events 14 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
Creatinine increased
|
72.2%
13/18 • Number of events 32 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Psychiatric disorders
Depression
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
6/18 • Number of events 6 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Nervous system disorders
Dizziness
|
33.3%
6/18 • Number of events 9 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Eye disorders
Dry eye
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
2/18 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
2/18 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Nervous system disorders
Dysgeusia
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
3/18 • Number of events 5 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Dysphagia
|
11.1%
2/18 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
4/18 • Number of events 5 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
General disorders
Edema face
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
General disorders
Edema limbs
|
16.7%
3/18 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.6%
1/18 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Ear and labyrinth disorders
External ear pain
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Eye disorders
Eye disorders - Other, specify
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
2/18 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
General disorders
Fatigue
|
55.6%
10/18 • Number of events 18 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
General disorders
Fever
|
22.2%
4/18 • Number of events 6 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
3/18 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Eye disorders
Floaters
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Vascular disorders
Flushing
|
11.1%
2/18 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Infections and infestations
Folliculitis
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
GGT increased
|
5.6%
1/18 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Abdominal pain
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Alveolar bone loss
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Left side jaw pain
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Wisdom tooth extraction
|
11.1%
2/18 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
General disorders
Generalized edema
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Nervous system disorders
Headache
|
50.0%
9/18 • Number of events 17 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Renal and urinary disorders
Hematuria
|
11.1%
2/18 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Vascular disorders
Hot flashes
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
3/18 • Number of events 9 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
44.4%
8/18 • Number of events 38 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
3/18 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
6/18 • Number of events 10 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.1%
2/18 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
11.1%
2/18 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
22.2%
4/18 • Number of events 6 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Vascular disorders
Hypertension
|
33.3%
6/18 • Number of events 17 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Endocrine disorders
Hyperthyroidism
|
11.1%
2/18 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
3/18 • Number of events 5 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
88.9%
16/18 • Number of events 55 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
11.1%
2/18 • Number of events 5 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
22.2%
4/18 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
27.8%
5/18 • Number of events 9 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
55.6%
10/18 • Number of events 33 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
3/18 • Number of events 6 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Vascular disorders
Hypotension
|
44.4%
8/18 • Number of events 10 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Endocrine disorders
Hypothyroidism
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
3/18 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Psychiatric disorders
Insomnia
|
22.2%
4/18 • Number of events 5 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
Investigations - Other, RBC Urin increased
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
Investigations - Other, WBC Urine
|
5.6%
1/18 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
Investigations - Other, pro Brain Natriuretic peptide
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
General disorders
Localized edema
|
55.6%
10/18 • Number of events 19 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Infections and infestations
Lung infection
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
Lymphocyte count decreased
|
94.4%
17/18 • Number of events 74 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
3/18 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
9/18 • Number of events 18 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
Neutrophil count decreased
|
11.1%
2/18 • Number of events 6 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
27.8%
5/18 • Number of events 9 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Oral pain
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
General disorders
Pain
|
27.8%
5/18 • Number of events 6 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
38.9%
7/18 • Number of events 9 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
11.1%
2/18 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Nervous system disorders
Paresthesia
|
5.6%
1/18 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Infections and infestations
Penile infection
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Cardiac disorders
Pericardial effusion
|
16.7%
3/18 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
Platelet count decreased
|
27.8%
5/18 • Number of events 9 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
2/18 • Number of events 2 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Nervous system disorders
Presyncope
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
3/18 • Number of events 6 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
3/18 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.1%
2/18 • Number of events 4 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
16.7%
3/18 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Cardiac disorders
Sinus tachycardia
|
44.4%
8/18 • Number of events 12 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Erythema abigne
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other,Left arm distal to IV site
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Lesion right forearm
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, left shoulder and left leg
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, pimple located on top of gluteal cleft
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Nervous system disorders
Somnolence
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
3/18 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Vascular disorders
Thromboembolic event
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Endocrine disorders
Thyroid stimulating hormone increased
|
27.8%
5/18 • Number of events 8 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Toothache
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Nervous system disorders
Tremor
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Renal and urinary disorders
Urinary frequency
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Gastrointestinal disorders
Vomiting
|
27.8%
5/18 • Number of events 7 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
Weight gain
|
55.6%
10/18 • Number of events 16 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
Weight loss
|
38.9%
7/18 • Number of events 13 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.6%
1/18 • Number of events 1 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
|
Investigations
White blood cell decreased
|
16.7%
3/18 • Number of events 3 • Date treatment consent signed to date off study, approximately 22 months and 29 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place