Trial Outcomes & Findings for Paclitaxel + Bevacizumab (Avastin) for the Treatment of Metastatic or Unresectable Angiosarcoma (NCT NCT01055028)
NCT ID: NCT01055028
Last Updated: 2018-03-26
Results Overview
The primary objective of this study was to evaluate progression-free survival (PFS or non-progression rate) through 4 months from start of treatment. Progression is defined as ≥ 20% increase in the sum of the longest diameter of target lesions, as compared to the baseline measurements, and/or the appearance of one or more new lesion(s).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
4 months
Results posted on
2018-03-26
Participant Flow
Participant milestones
| Measure |
Regimen A Treatment 1
Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.
Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
|
Regimen B Treatment 2
Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.
Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
|
|---|---|---|
|
Screening
STARTED
|
9
|
9
|
|
Screening
COMPLETED
|
8
|
8
|
|
Screening
NOT COMPLETED
|
1
|
1
|
|
Treatment Cycles 1 to 3
STARTED
|
8
|
8
|
|
Treatment Cycles 1 to 3
COMPLETED
|
6
|
5
|
|
Treatment Cycles 1 to 3
NOT COMPLETED
|
2
|
3
|
|
Inter-treatment Period
STARTED
|
6
|
5
|
|
Inter-treatment Period
COMPLETED
|
6
|
2
|
|
Inter-treatment Period
NOT COMPLETED
|
0
|
3
|
|
Treatment Cycles 4 to 6
STARTED
|
6
|
2
|
|
Treatment Cycles 4 to 6
COMPLETED
|
6
|
2
|
|
Treatment Cycles 4 to 6
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Regimen A Treatment 1
Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.
Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
|
Regimen B Treatment 2
Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.
Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
|
|---|---|---|
|
Screening
Screen Failure
|
1
|
1
|
|
Treatment Cycles 1 to 3
Adverse Event
|
0
|
1
|
|
Treatment Cycles 1 to 3
Discontinued, < 3 cycles treatment
|
2
|
2
|
|
Inter-treatment Period
Did not start Cycle 4
|
0
|
3
|
Baseline Characteristics
Paclitaxel + Bevacizumab (Avastin) for the Treatment of Metastatic or Unresectable Angiosarcoma
Baseline characteristics by cohort
| Measure |
Regimen A Treatment 1
n=9 Participants
Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.
Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
|
Regimen B Treatment 2
n=9 Participants
Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.
Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
|
Total
n=18 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
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: Includes all subjects that started treatment
The primary objective of this study was to evaluate progression-free survival (PFS or non-progression rate) through 4 months from start of treatment. Progression is defined as ≥ 20% increase in the sum of the longest diameter of target lesions, as compared to the baseline measurements, and/or the appearance of one or more new lesion(s).
Outcome measures
| Measure |
Regimen A Treatment 1
n=8 Participants
Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.
Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
|
Regimen B Treatment 2
n=8 Participants
Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.
Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
4 Participants without disease progression
|
5 Participants without disease progression
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Includes participants that complete 3 cycles of treatment
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria, per protocol. Overall response rate (ORR) is the sum of the Complete Response (CR) + Partial Response (PR) rates. The ORR for participants after 3 cycles of treatment (12 weeks) is expressed as the number and proportion of subjects. RECIST Criteria * CR = Disappearance of all target lesions * PR = ≥ 30% decrease in the sum of the longest diameter of target lesions * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s), * Stable disease (SD) = Small changes that do not meet any of the above criteria
Outcome measures
| Measure |
Regimen A Treatment 1
n=6 Participants
Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.
Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
|
Regimen B Treatment 2
n=5 Participants
Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.
Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
|
|---|---|---|
|
Overall Response Rate After 3 Cycles
Complete Response (CR)
|
1 Participants
|
0 Participants
|
|
Overall Response Rate After 3 Cycles
Partial Response (PR)
|
2 Participants
|
2 Participants
|
|
Overall Response Rate After 3 Cycles
Stable Disease (SD)
|
1 Participants
|
2 Participants
|
|
Overall Response Rate After 3 Cycles
Progressive Disease (PD)
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 CyclesPopulation: Includes participants that complete 6 cycles of treatment
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria, per protocol. Overall response rate (ORR) is the sum of the Complete Response (CR) + Partial Response (PR) rates. The ORR for participants after 6 cycles of treatment (24 weeks) is expressed as the number and proportion of subjects. RECIST Criteria * CR = Disappearance of all target lesions * PR = ≥ 30% decrease in the sum of the longest diameter of target lesions * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions, and/or the appearance of one or more new lesion(s), * Stable disease (SD) = Small changes that do not meet any of the above criteria
Outcome measures
| Measure |
Regimen A Treatment 1
n=6 Participants
Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.
Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
|
Regimen B Treatment 2
n=2 Participants
Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.
Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
|
|---|---|---|
|
Overall Response Rate After 6th Cycle
Complete Response (CR)
|
1 Participants
|
0 Participants
|
|
Overall Response Rate After 6th Cycle
Partial Response (PR)
|
2 Participants
|
0 Participants
|
|
Overall Response Rate After 6th Cycle
Stable Disease (SD)
|
1 Participants
|
1 Participants
|
|
Overall Response Rate After 6th Cycle
Progressive Disease (PD)
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsAssessed as the number of subjects known to remain alive 6 months after study entry
Outcome measures
| Measure |
Regimen A Treatment 1
n=8 Participants
Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.
Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
|
Regimen B Treatment 2
n=8 Participants
Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.
Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
|
|---|---|---|
|
Overall Survival (OS) at 6 Months
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 monthsAssessed as the number of subjects known to remain alive 12 months after study entry
Outcome measures
| Measure |
Regimen A Treatment 1
n=8 Participants
Participants were to receive paclitaxel 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.
Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
|
Regimen B Treatment 2
n=8 Participants
Patients were to receive paclitaxel 90 mg/m² weekly x 3 of a 28-day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3 to 6: 30 min) every 21 days x 6 cycles.
Maintenance bevacizumab (MB), 15 mg/kg once every 21 days intravenously for a maximum of 8 cycles, was initiated after the completion of paclitaxel + bevacizumab combination.
|
|---|---|---|
|
Overall Survival (OS) at 12 Months
|
6 Participants
|
6 Participants
|
Adverse Events
Regimen A Treatment 1
Serious events: 8 serious events
Other events: 8 other events
Deaths: 0 deaths
Regimen B Treatment 2
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regimen A Treatment 1
n=8 participants at risk
Patients were to receive paclitaxel (A) 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of a combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles.
|
Regimen B Treatment 2
n=8 participants at risk
Patients were to receive paclitaxel (B) 90 mg/m² weekly x 3 of a 28 day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of a combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Cardiac disorders
Congestive heart failure
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Increased right hip pain
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
General disorders
Fever
|
12.5%
1/8 • Number of events 1 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Renal and urinary disorders
Urinary tract infection
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Gastrointestinal disorders
Colon perforation
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Cardiac disorders
Circumflex artery occlusion
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
General disorders
Progression of aggressive tumor
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Cardiac disorders
Pleuritic right chest pain
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
Other adverse events
| Measure |
Regimen A Treatment 1
n=8 participants at risk
Patients were to receive paclitaxel (A) 200 mg/m² intravenously over 3 hours every 21 days followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of a combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles.
|
Regimen B Treatment 2
n=8 participants at risk
Patients were to receive paclitaxel (B) 90 mg/m² weekly x 3 of a 28 day cycle followed by bevacizumab 15 mg/kg intravenously over (cycle 1: 90 min; cycle 2: 60 min; cycles 3-6: 30 min) every 21 days x 6 cycles. Maintenance bevacizumab (MB) started after the completion of a combination of paclitaxel and bevacizumab and it was given at a dose of 15 mg/kg intravenously once every 21 days for a maximum of 8 cycles.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 2 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Intermittent nausea
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • Number of events 2 • 7 years
|
0.00%
0/8 • 7 years
|
|
Gastrointestinal disorders
Intermittent vomiting
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Intermittent diarrhea
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Gastrointestinal disorders
Intermittent stomach pain/ache
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Gastrointestinal disorders
Occasional indigestion
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Anorexia
|
25.0%
2/8 • Number of events 2 • 7 years
|
37.5%
3/8 • Number of events 3 • 7 years
|
|
Gastrointestinal disorders
Occasional abdominal pain
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Gas pain
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Dysphagia intermittent
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • Number of events 1 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Worsening pain left flank
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Gastrointestinal disorders
Mouth sores
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Gastrointestinal disorders
Mouth irritation
|
12.5%
1/8 • Number of events 1 • 7 years
|
25.0%
2/8 • Number of events 2 • 7 years
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Ateration in taste
|
0.00%
0/8 • 7 years
|
25.0%
2/8 • Number of events 2 • 7 years
|
|
Gastrointestinal disorders
Metallic taste
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
62.5%
5/8 • Number of events 6 • 7 years
|
62.5%
5/8 • Number of events 5 • 7 years
|
|
Gastrointestinal disorders
Sore throat
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Psychiatric disorders
Insomnia
|
25.0%
2/8 • Number of events 2 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
General disorders
Fatigue
|
50.0%
4/8 • Number of events 6 • 7 years
|
50.0%
4/8 • Number of events 5 • 7 years
|
|
General disorders
Headache
|
12.5%
1/8 • Number of events 1 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
General disorders
Fever
|
37.5%
3/8 • Number of events 3 • 7 years
|
0.00%
0/8 • 7 years
|
|
General disorders
Intermittent fever
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Vascular disorders
Worsened hypertension
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Nervous system disorders
Intermittent dizziness
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Nervous system disorders
Lightheadedness
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Body aches
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Restless legs
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8 • Number of events 1 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Nervous system disorders
Peripheral neuropathy
|
25.0%
2/8 • Number of events 2 • 7 years
|
0.00%
0/8 • 7 years
|
|
Nervous system disorders
Worsening peripheral neuropathy
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Nervous system disorders
Neuropathy feet
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Nervous system disorders
Neuropathy toes
|
37.5%
3/8 • Number of events 3 • 7 years
|
0.00%
0/8 • 7 years
|
|
Nervous system disorders
Numbness/tingling feet
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Nervous system disorders
Numbness/tingling hands
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Nervous system disorders
Neuropathy fingertips
|
25.0%
2/8 • Number of events 2 • 7 years
|
25.0%
2/8 • Number of events 2 • 7 years
|
|
Nervous system disorders
Sensory neuropathy fingers/toes
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Gastrointestinal disorders
Intermittent xerostomia
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Nervous system disorders
Sensory neuropathy both lower extremities
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Nervous system disorders
Tingling fingertips
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Pain left leg
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Musculoskeletal and connective tissue disorders
occasional pain on left scalp
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.0%
2/8 • Number of events 2 • 7 years
|
0.00%
0/8 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Pain left face
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Worsened R hip pain
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia intermittent
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis intermittent
|
0.00%
0/8 • 7 years
|
37.5%
3/8 • Number of events 3 • 7 years
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
2/8 • Number of events 4 • 7 years
|
25.0%
2/8 • Number of events 2 • 7 years
|
|
Infections and infestations
Bacteremia
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Psychiatric disorders
Delerium
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Psychiatric disorders
Agitation
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Investigations
Neutropenia
|
50.0%
4/8 • Number of events 4 • 7 years
|
87.5%
7/8 • Number of events 7 • 7 years
|
|
Investigations
Thrombocytopenia
|
37.5%
3/8 • Number of events 8 • 7 years
|
0.00%
0/8 • 7 years
|
|
Investigations
Elevated alkaline phosphatase
|
37.5%
3/8 • Number of events 8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Investigations
Elevated Aspartate Aminotransferase
|
12.5%
1/8 • Number of events 1 • 7 years
|
25.0%
2/8 • Number of events 2 • 7 years
|
|
Investigations
Elevated Alanine Aminotransferease
|
12.5%
1/8 • Number of events 2 • 7 years
|
12.5%
1/8 • Number of events 4 • 7 years
|
|
Investigations
Hyperbilirubinemia
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
2/8 • Number of events 2 • 7 years
|
0.00%
0/8 • 7 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
37.5%
3/8 • Number of events 4 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
2/8 • Number of events 2 • 7 years
|
0.00%
0/8 • 7 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Metabolism and nutrition disorders
Elevated uric acid
|
12.5%
1/8 • Number of events 2 • 7 years
|
0.00%
0/8 • 7 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Metabolism and nutrition disorders
Elevated potassium
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Investigations
Prolonged international normalized ratio
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Investigations
Increased creatinine
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Investigations
Increased B-natriuretic peptide
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
2/8 • Number of events 2 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea-Occasional
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Increasing shortness of breath
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Skin and subcutaneous tissue disorders
Easy bruising
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
General disorders
Gait disorder
|
25.0%
2/8 • Number of events 2 • 7 years
|
0.00%
0/8 • 7 years
|
|
General disorders
Hot flashes occasional
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral crackles lungs
|
12.5%
1/8 • Number of events 1 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
General disorders
Weakness
|
25.0%
2/8 • Number of events 3 • 7 years
|
0.00%
0/8 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Pain-Myalgia
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Eye disorders
Change in vision
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Difficulty walking
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Eye disorders
Eye irritation
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Skin and subcutaneous tissue disorders
Pruritus nontargert lesion
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Skin and subcutaneous tissue disorders
Rash on extremites
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Skin and subcutaneous tissue disorders
Rash chest
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Skin and subcutaneous tissue disorders
Rash back of neck
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/8 • 7 years
|
37.5%
3/8 • Number of events 4 • 7 years
|
|
Skin and subcutaneous tissue disorders
Nail infection
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 2 • 7 years
|
|
Skin and subcutaneous tissue disorders
Skin changes
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Skin and subcutaneous tissue disorders
Erythema face
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Skin and subcutaneous tissue disorders
Skin peeling face
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
General disorders
Cold intolerance
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Nervous system disorders
Memory impairment
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Increased oral cavity bleeding
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Weight loss
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Hemoptysis
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
General disorders
Voice changes
|
25.0%
2/8 • Number of events 2 • 7 years
|
0.00%
0/8 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Edema left arm
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Reproductive system and breast disorders
Vaginal dryness
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Ear and labyrinth disorders
Earache
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Skin and subcutaneous tissue disorders
Scalp tightness
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • 7 years
|
25.0%
2/8 • Number of events 2 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
2/8 • Number of events 2 • 7 years
|
0.00%
0/8 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus infection
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Cardiac disorders
Sinus Tachycardia
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Abdominal pain
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Infections and infestations
Afebrile neutropenia
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Skin and subcutaneous tissue disorders
Edema Left hand
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Skin and subcutaneous tissue disorders
Edema left knee
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
General disorders
Headache-occasional
|
12.5%
1/8 • Number of events 1 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Blood and lymphatic system disorders
Hemoglobinemia
|
37.5%
3/8 • Number of events 10 • 7 years
|
25.0%
2/8 • Number of events 3 • 7 years
|
|
Skin and subcutaneous tissue disorders
Hyperpigmented macule
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Infections and infestations
Intermittent fever
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Intermittent leg cramps
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Nervous system disorders
Neuropathic pain feet
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Nervous system disorders
Night sweats
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Blood and lymphatic system disorders
Nose hemorrhage
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Pain left chest wall- occasional
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Blood and lymphatic system disorders
Worsened anemia
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Nervous system disorders
Numbness tingling toes/soles
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Skin and subcutaneous tissue disorders
Rash arms
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Skin and subcutaneous tissue disorders
Rash legs
|
12.5%
1/8 • Number of events 1 • 7 years
|
0.00%
0/8 • 7 years
|
|
Blood and lymphatic system disorders
Occasional hypertension
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Musculoskeletal and connective tissue disorders
Pain right hip
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Occasional diarrhea
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Nervous system disorders
Occasional headache
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Gastrointestinal disorders
Occasional nausea
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Blood and lymphatic system disorders
Occasional Hypomagnesemia
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Blood and lymphatic system disorders
Occasional hyponatremia
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
|
Investigations
Oral irritation
|
0.00%
0/8 • 7 years
|
12.5%
1/8 • Number of events 1 • 7 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place