Trial Outcomes & Findings for Pembro and HER2Bi-Armed Activated T Cells in Treating Patients With Metastatic Castration Resistant Prostate Cancer (NCT NCT03406858)
NCT ID: NCT03406858
Last Updated: 2023-05-03
Results Overview
Percentage of patients achieving clinical progression-free interval at 6 months from study registration
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2023-05-03
Participant Flow
One patient went through Pheresis but did not return for treatment. They were excluded from the Progression-Free Survival analysis but were included in adverse events since they began the process.
Participant milestones
| Measure |
Treatment (Pembrolizumab, HER2Bi-armed Activated T Cells)
Patients receive pembrolizumab IV over 30 minutes every 3 weeks. Treatment repeats every 3 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity. Beginning at least 1 week after pembrolizumab, patients receive HER2Bi-armed activated T cells IV over 5-15 minutes 2 times a week for 4 weeks in the absence of disease progression or unacceptable toxicity.
HER2Bi-Armed Activated T Cells: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Pembrolizumab, HER2Bi-armed Activated T Cells)
Patients receive pembrolizumab IV over 30 minutes every 3 weeks. Treatment repeats every 3 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity. Beginning at least 1 week after pembrolizumab, patients receive HER2Bi-armed activated T cells IV over 5-15 minutes 2 times a week for 4 weeks in the absence of disease progression or unacceptable toxicity.
HER2Bi-Armed Activated T Cells: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Overall Study
Failure to receive treatment drug.
|
1
|
|
Overall Study
ineligible
|
1
|
Baseline Characteristics
Pembro and HER2Bi-Armed Activated T Cells in Treating Patients With Metastatic Castration Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Pembrolizumab, HER2Bi-armed Activated T Cells)
n=13 Participants
Patients receive pembrolizumab IV over 30 minutes every 3 weeks. Treatment repeats every 3 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity. Beginning at least 1 week after pembrolizumab, patients receive HER2Bi-armed activated T cells IV over 5-15 minutes 2 times a week for 4 weeks in the absence of disease progression or unacceptable toxicity.
HER2Bi-Armed Activated T Cells: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
|
Age, Continuous
|
69 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsPopulation: All patients that received treatment. One patient went through Pheresis but never returned for treatment.
Percentage of patients achieving clinical progression-free interval at 6 months from study registration
Outcome measures
| Measure |
Treatment (Pembrolizumab, HER2Bi-armed Activated T Cells)
n=13 Participants
Patients receive pembrolizumab IV over 30 minutes every 3 weeks. Treatment repeats every 3 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity. Beginning at least 1 week after pembrolizumab, patients receive HER2Bi-armed activated T cells IV over 5-15 minutes 2 times a week for 4 weeks in the absence of disease progression or unacceptable toxicity.
HER2Bi-Armed Activated T Cells: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Progression-free Survival
|
38.5 percentage of participants
Interval 19.3 to 76.5
|
Adverse Events
Treatment (Pembrolizumab, HER2Bi-armed Activated T Cells)
Serious events: 7 serious events
Other events: 14 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Treatment (Pembrolizumab, HER2Bi-armed Activated T Cells)
n=14 participants at risk
Patients receive pembrolizumab IV over 30 minutes every 3 weeks. Treatment repeats every 3 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity. Beginning at least 1 week after pembrolizumab, patients receive HER2Bi-armed activated T cells IV over 5-15 minutes 2 times a week for 4 weeks in the absence of disease progression or unacceptable toxicity.
HER2Bi-Armed Activated T Cells: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Investigations
Alkaline phosphatase increased
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Blood and lymphatic system disorders
Anemia
|
21.4%
3/14 • Number of events 3 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
2/14 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
General disorders
Fatigue
|
14.3%
2/14 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Immune system disorders
Immune system disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Investigations
Lymphocyte count decreased
|
14.3%
2/14 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Investigations
Neutrophil count decreased
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
14.3%
2/14 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
Other adverse events
| Measure |
Treatment (Pembrolizumab, HER2Bi-armed Activated T Cells)
n=14 participants at risk
Patients receive pembrolizumab IV over 30 minutes every 3 weeks. Treatment repeats every 3 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity. Beginning at least 1 week after pembrolizumab, patients receive HER2Bi-armed activated T cells IV over 5-15 minutes 2 times a week for 4 weeks in the absence of disease progression or unacceptable toxicity.
HER2Bi-Armed Activated T Cells: Given IV
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Immune system disorders
Allergic reaction
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
14.3%
2/14 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.6%
4/14 • Number of events 4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
14.3%
2/14 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
General disorders
Chills
|
64.3%
9/14 • Number of events 9 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Investigations
Cholesterol high
|
14.3%
2/14 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Psychiatric disorders
Confusion
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Psychiatric disorders
Depression
|
14.3%
2/14 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
General disorders
Fatigue
|
78.6%
11/14 • Number of events 12 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
General disorders
Fever
|
14.3%
2/14 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
28.6%
4/14 • Number of events 6 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Nervous system disorders
Headache
|
50.0%
7/14 • Number of events 7 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Ear and labyrinth disorders
Hearing impaired
|
14.3%
2/14 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Vascular disorders
Hot flashes
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Vascular disorders
Hypertension
|
21.4%
3/14 • Number of events 3 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.3%
2/14 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
2/14 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Nervous system disorders
Memory impairment
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
14.3%
2/14 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Gastrointestinal disorders
Nausea
|
64.3%
9/14 • Number of events 9 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
General disorders
Pain
|
14.3%
2/14 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
21.4%
3/14 • Number of events 3 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Reproductive system and breast disorders
Pelvic pain
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
14.3%
2/14 • Number of events 4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
14.3%
2/14 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Psychiatric disorders
Restlessness
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Renal and urinary disorders
Urinary frequency
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Renal and urinary disorders
Urinary retention
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Vascular disorders
Vascular disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
4/14 • Number of events 4 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
General disorders
Edema limbs
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
General disorders
Infusion related reaction
|
7.1%
1/14 • Number of events 2 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Renal and urinary disorders
Urinary tract pain
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
7.1%
1/14 • Number of events 1 • For the time period beginning at treatment allocation/randomization through 90 days following cessation of treatment, or 30 days following cessation of treatment if the subject initiates new anticancer therapy, whichever is earlier, up to 6 months.
|
Additional Information
Dr. Abhinav Deol
Wayne State University/Karmanos Cancer Institute
Phone: 313-576-8093
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place