Trial Outcomes & Findings for Paclitaxel and Bevacizumab With or Without Emactuzumab in Treating Patients With Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT02923739)
NCT ID: NCT02923739
Last Updated: 2024-03-13
Results Overview
Safety is defined as no required dose alterations during the first cycle (4 weeks) of therapy due to a grade 3 or greater related adverse event.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to 4 weeks
Results posted on
2024-03-13
Participant Flow
The study was activated on 05/05/2017 and closed to new patient entry on 11/19/2018. The study was terminated on 09/27/2022 and all recruitment was done in a medical clinic setting.
Participant milestones
| Measure |
Safety Lead-In
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15, and Emactuzumab 1000 mg IV on Days 1 \& 15 on a 28 day cycle
|
Induction Arm
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15 on a 28 day cycle
|
Randomized Arm 1
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15 on a 28 day cycle
|
Randomized Arm 2
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15, and Emactuzumab 1000 mg IV on Days 1 \& 15 on a 28 day cycle
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
4
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Safety Lead-In
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15, and Emactuzumab 1000 mg IV on Days 1 \& 15 on a 28 day cycle
|
Induction Arm
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15 on a 28 day cycle
|
Randomized Arm 1
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15 on a 28 day cycle
|
Randomized Arm 2
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15, and Emactuzumab 1000 mg IV on Days 1 \& 15 on a 28 day cycle
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
|
Overall Study
Failed Screening
|
3
|
0
|
0
|
0
|
Baseline Characteristics
Paclitaxel and Bevacizumab With or Without Emactuzumab in Treating Patients With Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Safety Lead-In
n=9 Participants
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15, and Emactuzumab 1000 mg IV on Days 1 \& 15 on a 28 day cycle
|
Induction Arm
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15 on a 28 day cycle
|
Randomized Arm 1
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15 on a 28 day cycle
|
Randomized Arm 2
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15, and Emactuzumab 1000 mg IV on Days 1 \& 15 on a 28 day cycle
|
Total
n=9 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
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Age, Continuous
|
66 Years
n=5 Participants
|
—
|
—
|
—
|
66 Years
n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
—
|
—
|
—
|
9 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: The study was terminated early by the sponsor and no data was collected for the study objective was unable to be fully evaluated.
Safety is defined as no required dose alterations during the first cycle (4 weeks) of therapy due to a grade 3 or greater related adverse event.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At 32 weeksPopulation: The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
Will use a log-rank test.
Outcome measures
Outcome data not reported
Adverse Events
Safety Lead-In
Serious events: 4 serious events
Other events: 4 other events
Deaths: 5 deaths
Induction Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Randomized Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Randomized Arm 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Safety Lead-In
n=9 participants at risk
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15, and Emactuzumab 1000 mg IV on Days 1 \& 15 on a 28 day cycle
|
Induction Arm
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15 on a 28 day cycle
|
Randomized Arm 1
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15 on a 28 day cycle
|
Randomized Arm 2
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15, and Emactuzumab 1000 mg IV on Days 1 \& 15 on a 28 day cycle
|
|---|---|---|---|---|
|
Investigations
CPK increased
|
44.4%
4/9 • Number of events 6 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
Other adverse events
| Measure |
Safety Lead-In
n=9 participants at risk
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15, and Emactuzumab 1000 mg IV on Days 1 \& 15 on a 28 day cycle
|
Induction Arm
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15 on a 28 day cycle
|
Randomized Arm 1
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15 on a 28 day cycle
|
Randomized Arm 2
Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15, and Emactuzumab 1000 mg IV on Days 1 \& 15 on a 28 day cycle
|
|---|---|---|---|---|
|
Investigations
LDH increased
|
44.4%
4/9 • Number of events 14 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Renal and urinary disorders
Acute kidney injury
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Skin and subcutaneous tissue disorders
Alopcia
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Blood and lymphatic system disorders
Anemia
|
44.4%
4/9 • Number of events 16 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Investigations
SGOT increased
|
44.4%
4/9 • Number of events 13 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Investigations
CPK increased
|
44.4%
4/9 • Number of events 18 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Investigations
Creatinine increased
|
11.1%
1/9 • Number of events 3 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
1/9 • Number of events 2 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
2/9 • Number of events 3 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Nervous system disorders
Dysphasia
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
General disorders
Ear and labyrinth disorders
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
General disorders
Edema - face
|
22.2%
2/9 • Number of events 2 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
General disorders
Eye disorders - conjunctival chemosis
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
General disorders
Fatigue
|
44.4%
4/9 • Number of events 5 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Investigations
GGT increased
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Vascular disorders
Hypertension
|
44.4%
4/9 • Number of events 21 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
General disorders
Malaise
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Gastrointestinal disorders
Mucositis oral
|
22.2%
2/9 • Number of events 3 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Investigations
Neutrophil count decreased
|
11.1%
1/9 • Number of events 2 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Gastrointestinal disorders
Oral pain
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
General disorders
Pain
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythodysesthesia syndrome
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Infections and infestations
Paronychia
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Renal and urinary disorders
Proteinuria
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
22.2%
2/9 • Number of events 2 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Infections and infestations
Urinary tract infection
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Renal and urinary disorders
Urinary tract obstruction
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
|
Investigations
Urinary tract obstruction
|
11.1%
1/9 • Number of events 1 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
—
0/0 • 1 year
The study was terminated early by the sponsor and the study objective was unable to be fully evaluated
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place