Trial Outcomes & Findings for Abraxane® With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer (NCT NCT02788981)
NCT ID: NCT02788981
Last Updated: 2025-06-10
Results Overview
Measured using the RECIST guideline v1.1
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
12 months
Results posted on
2025-06-10
Participant Flow
Participant milestones
| Measure |
Nab-Paclitaxel+Mifepristone
Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)
Mifepristone: Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
Nab-Paclitaxel: Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
|
Nab-Paclitaxel+Placebo
Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)
Placebo: Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
Nab-Paclitaxel: Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
16
|
|
Overall Study
COMPLETED
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Nab-Paclitaxel+Mifepristone
Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)
Mifepristone: Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
Nab-Paclitaxel: Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
|
Nab-Paclitaxel+Placebo
Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)
Placebo: Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
Nab-Paclitaxel: Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
|
|---|---|---|
|
Overall Study
Patient chose to pursue alternative treatment
|
0
|
1
|
Baseline Characteristics
Abraxane® With or Without Mifepristone for Advanced, Glucocorticoid Receptor-Positive, Triple-Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Nab-Paclitaxel+Mifepristone
n=13 Participants
Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)
Mifepristone: Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
Nab-Paclitaxel: Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
|
Nab-Paclitaxel+Placebo
n=16 Participants
Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)
Placebo: Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
Nab-Paclitaxel: Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 13 • n=99 Participants
|
49 years
STANDARD_DEVIATION 10 • n=107 Participants
|
53 years
STANDARD_DEVIATION 12 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
16 participants
n=107 Participants
|
29 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsMeasured using the RECIST guideline v1.1
Outcome measures
| Measure |
Nab-Paclitaxel+Mifepristone
n=13 Participants
Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)
Mifepristone: Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
Nab-Paclitaxel: Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
|
Nab-Paclitaxel+Placebo
n=13 Participants
Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)
Placebo: Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
Nab-Paclitaxel: Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
3.0 months
Interval 1.0 to 5.0
|
3.0 months
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data on glucocorticoid receptor positivity was not collected.
Compare the response rate in GR positivity between the placebo and mifepristone groups using the RECIST guideline v1.1
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsMeasured using the RECIST guideline v1.1
Outcome measures
| Measure |
Nab-Paclitaxel+Mifepristone
n=13 Participants
Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)
Mifepristone: Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
Nab-Paclitaxel: Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
|
Nab-Paclitaxel+Placebo
n=13 Participants
Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)
Placebo: Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
Nab-Paclitaxel: Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
|
|---|---|---|
|
Response Rate
Responder
|
3 Participants
|
5 Participants
|
|
Response Rate
Non-Responder
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 24 monthsCollected from date of randomization until death
Outcome measures
| Measure |
Nab-Paclitaxel+Mifepristone
n=13 Participants
Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)
Mifepristone: Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
Nab-Paclitaxel: Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
|
Nab-Paclitaxel+Placebo
n=14 Participants
Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)
Placebo: Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
Nab-Paclitaxel: Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
|
|---|---|---|
|
Overall Survival
|
9.0 months
Interval 6.0 to 28.0
|
6.0 months
Interval 2.0 to 15.0
|
Adverse Events
Nab-Paclitaxel+Mifepristone
Serious events: 2 serious events
Other events: 13 other events
Deaths: 12 deaths
Nab-Paclitaxel+Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Nab-Paclitaxel+Mifepristone
n=13 participants at risk
Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)
Mifepristone: Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
Nab-Paclitaxel: Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
|
Nab-Paclitaxel+Placebo
n=15 participants at risk
Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)
Placebo: Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
Nab-Paclitaxel: Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
|
|---|---|---|
|
General disorders
Fatigue
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Blood and lymphatic system disorders
Anemia
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
Other adverse events
| Measure |
Nab-Paclitaxel+Mifepristone
n=13 participants at risk
Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)
Mifepristone: Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
Nab-Paclitaxel: Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
|
Nab-Paclitaxel+Placebo
n=15 participants at risk
Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle)
Placebo: Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
Nab-Paclitaxel: Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • 24 months or until the subject is off study
|
26.7%
4/15 • 24 months or until the subject is off study
|
|
Gastrointestinal disorders
Constipation
|
15.4%
2/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Gastrointestinal disorders
Diarrhea
|
30.8%
4/13 • 24 months or until the subject is off study
|
6.7%
1/15 • 24 months or until the subject is off study
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Metabolism and nutrition disorders
Anorexia
|
38.5%
5/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Blood and lymphatic system disorders
Anemia
|
23.1%
3/13 • 24 months or until the subject is off study
|
6.7%
1/15 • 24 months or until the subject is off study
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Nervous system disorders
Headache
|
15.4%
2/13 • 24 months or until the subject is off study
|
6.7%
1/15 • 24 months or until the subject is off study
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
46.2%
6/13 • 24 months or until the subject is off study
|
46.7%
7/15 • 24 months or until the subject is off study
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Nervous system disorders
Neuropathy
|
61.5%
8/13 • 24 months or until the subject is off study
|
33.3%
5/15 • 24 months or until the subject is off study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.1%
3/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
General disorders
Fever
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
General disorders
Fatigue
|
53.8%
7/13 • 24 months or until the subject is off study
|
66.7%
10/15 • 24 months or until the subject is off study
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
23.1%
3/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
General disorders
Neck stiffness
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Gastrointestinal disorders
abdominal pain
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
General disorders
Flu like symptoms
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
General disorders
Peripheral edema
|
7.7%
1/13 • 24 months or until the subject is off study
|
6.7%
1/15 • 24 months or until the subject is off study
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Vascular disorders
Hot flashes
|
7.7%
1/13 • 24 months or until the subject is off study
|
6.7%
1/15 • 24 months or until the subject is off study
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Renal and urinary disorders
Bladder spasms
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13 • 24 months or until the subject is off study
|
6.7%
1/15 • 24 months or until the subject is off study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • 24 months or until the subject is off study
|
6.7%
1/15 • 24 months or until the subject is off study
|
|
Eye disorders
Ocular edema
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Investigations
Bilirubinemia
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
General disorders
Non-cardiac chest pains
|
15.4%
2/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • 24 months or until the subject is off study
|
6.7%
1/15 • 24 months or until the subject is off study
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.1%
3/13 • 24 months or until the subject is off study
|
13.3%
2/15 • 24 months or until the subject is off study
|
|
Musculoskeletal and connective tissue disorders
Extremity pain
|
7.7%
1/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Gastrointestinal disorders
Mucositis
|
15.4%
2/13 • 24 months or until the subject is off study
|
0.00%
0/15 • 24 months or until the subject is off study
|
|
Nervous system disorders
Dysgeusia
|
46.2%
6/13 • 24 months or until the subject is off study
|
13.3%
2/15 • 24 months or until the subject is off study
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
23.1%
3/13 • 24 months or until the subject is off study
|
6.7%
1/15 • 24 months or until the subject is off study
|
|
Investigations
Neutropenia
|
46.2%
6/13 • 24 months or until the subject is off study
|
6.7%
1/15 • 24 months or until the subject is off study
|
|
Investigations
Transaminitis
|
7.7%
1/13 • 24 months or until the subject is off study
|
13.3%
2/15 • 24 months or until the subject is off study
|
|
Investigations
Thrombocytopenia
|
7.7%
1/13 • 24 months or until the subject is off study
|
6.7%
1/15 • 24 months or until the subject is off study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place