Trial Outcomes & Findings for Pembrolizumab in Metastatic Castration Resistant Prostate Cancer (mCRPC) With or Without DNA Damage Repair Defects (NCT NCT03248570)
NCT ID: NCT03248570
Last Updated: 2024-11-20
Results Overview
The rPFS rate is defined as the proportion of participants still alive at 6 months starting from the first day of study treatment with pembrolizumab. Participants will be censored on the date of documented tumor progression according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines or death due to any cause at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. The 6-month rPFS rate and the 95% confidence interval will be reported by study group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Up to 6 months
Results posted on
2024-11-20
Participant Flow
Participant milestones
| Measure |
DNA Damage Repair Proficient Group
Participants with mismatch repair (MMR) intact receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
DNA Damage Repair Defective Group
Participants with defective DNA repair receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab in Metastatic Castration Resistant Prostate Cancer (mCRPC) With or Without DNA Damage Repair Defects
Baseline characteristics by cohort
| Measure |
DNA Damage Repair Proficient Group
n=14 Participants
Participants with mismatch repair (MMR) intact receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
DNA Damage Repair Defective Group
n=12 Participants
Participants with defective DNA repair receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
50-59 years old
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Customized
60-69 years old
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Customized
70-79 years old
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Customized
80-89 years old
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 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
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
12 participants
n=107 Participants
|
26 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 6 monthsThe rPFS rate is defined as the proportion of participants still alive at 6 months starting from the first day of study treatment with pembrolizumab. Participants will be censored on the date of documented tumor progression according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines or death due to any cause at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. The 6-month rPFS rate and the 95% confidence interval will be reported by study group.
Outcome measures
| Measure |
DNA Damage Repair Proficient Group
n=14 Participants
Participants with mismatch repair (MMR) intact receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
DNA Damage Repair Defective Group
n=12 Participants
Participants with defective DNA repair receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
|---|---|---|
|
Radiographic Progression-Free Survival Rate (rPFS) at 6 Months
|
0.513 proportion of participants
Interval 0.296 to 0.888
|
0.63 proportion of participants
Interval 0.402 to 1.0
|
PRIMARY outcome
Timeframe: Up to 24 monthsThe median overall radiographic progression free survival (rPFS) is defined as the time from the first day of study treatment with pembrolizumab to the date of documented radiographic tumor progression according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines or death due to any cause, whichever occurs first. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. The median time in months and the 95% confidence interval will be reported by study group.
Outcome measures
| Measure |
DNA Damage Repair Proficient Group
n=14 Participants
Participants with mismatch repair (MMR) intact receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
DNA Damage Repair Defective Group
n=12 Participants
Participants with defective DNA repair receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
|---|---|---|
|
Median Overall Radiographic Progression-free Survival (rPFS)
|
10.43 months
Interval 4.28 to
The upper range of the confidence interval was calculated to be infinity
|
7.89 months
Interval 4.61 to
The upper range of the confidence interval was calculated to be infinity
|
SECONDARY outcome
Timeframe: Up to 20 weeksThe immune-related Progression Free Survival rate (irPFS) is defined as the proportion of participants still alive at 20 weeks from the first day of study treatment with pembrolizumab. Participants will be censored on the date of documented tumor progression according to the immune-related response criteria (irRC) for immune-related progression or death due to any cause at 20 weeks. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. The 20-week irPFS rate and the 95% confidence interval will be reported by study group.
Outcome measures
| Measure |
DNA Damage Repair Proficient Group
n=14 Participants
Participants with mismatch repair (MMR) intact receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
DNA Damage Repair Defective Group
n=12 Participants
Participants with defective DNA repair receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
|---|---|---|
|
Immune-related Progression-free Survival Rate (irPFS) at 20 Weeks
|
0.513 proportion of participants
Interval 0.296 to 0.888
|
0.648 proportion of participants
Interval 0.421 to 0.998
|
SECONDARY outcome
Timeframe: Up to 28 weeksThe immune-related Progression Free Survival rate (irPFS) is defined as the proportion of participants still alive at 28 weeks from the first day of study treatment with pembrolizumab. Participants will be censored on the date of documented tumor progression according to the immune-related response criteria (irRC) for immune-related progression or death due to any cause at 28 weeks. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. The 28-week irPFS rate and the 95% confidence interval will be reported by study group.
Outcome measures
| Measure |
DNA Damage Repair Proficient Group
n=14 Participants
Participants with mismatch repair (MMR) intact receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
DNA Damage Repair Defective Group
n=12 Participants
Participants with defective DNA repair receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
|---|---|---|
|
Immune-related Progression-free Survival Rate (irPFS) at 28 Weeks
|
0.513 proportion of participants
Interval 0.296 to 0.888
|
0.648 proportion of participants
Interval 0.421 to 0.998
|
SECONDARY outcome
Timeframe: Up to 20 weeksThe overall progression free survival rate (PFS) is defined as the proportion of participants still alive from the first day of study treatment with pembrolizumab at 20 weeks. Participants will be censored on the date of documented tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines or death due to any cause at 20 weeks. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. The 20-week overall PFS rate and the 95% confidence interval will be reported by study group.
Outcome measures
| Measure |
DNA Damage Repair Proficient Group
n=14 Participants
Participants with mismatch repair (MMR) intact receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
DNA Damage Repair Defective Group
n=12 Participants
Participants with defective DNA repair receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
|---|---|---|
|
Overall Progression-Free Survival Rate (PFS) at 20 Weeks
|
0.462 proportion of participants
Interval 0.257 to 0.83
|
0.556 proportion of participants
Interval 0.328 to 0.941
|
SECONDARY outcome
Timeframe: Up to 28 weeksThe overall progression free survival rate (PFS) is defined as the proportion of participants still alive from the first day of study treatment with pembrolizumab at 28 weeks. Participants will be censored on the date of documented tumor progression using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines or death due to any cause at 28 weeks. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. The 28-week overall PFS rate and the 95% confidence interval will be reported by study group.
Outcome measures
| Measure |
DNA Damage Repair Proficient Group
n=14 Participants
Participants with mismatch repair (MMR) intact receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
DNA Damage Repair Defective Group
n=12 Participants
Participants with defective DNA repair receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
|---|---|---|
|
Overall Progression-Free Survival Rate (PFS) at 28 Weeks
|
0.462 proportion of participants
Interval 0.257 to 0.83
|
0.556 proportion of participants
Interval 0.328 to 0.941
|
SECONDARY outcome
Timeframe: Up to 24 monthsThe percentage of participants with a demonstrated PSA response will be reported for each group along with the 95% confidence interval.
Outcome measures
| Measure |
DNA Damage Repair Proficient Group
n=14 Participants
Participants with mismatch repair (MMR) intact receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
DNA Damage Repair Defective Group
n=12 Participants
Participants with defective DNA repair receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
|---|---|---|
|
Percentage of Participants Achieving Any Prostate Specific Antigen (PSA) Response
|
57.1 percentage of participants
Interval 28.9 to 82.3
|
58.3 percentage of participants
Interval 27.7 to 84.8
|
SECONDARY outcome
Timeframe: Up to 24 monthsThe percentage of participants with a demonstrated PSA decline \>= 50% will be reported for each group along with the 95% confidence interval.
Outcome measures
| Measure |
DNA Damage Repair Proficient Group
n=14 Participants
Participants with mismatch repair (MMR) intact receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
DNA Damage Repair Defective Group
n=12 Participants
Participants with defective DNA repair receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
|---|---|---|
|
Percentage of Participants Achieving Any PSA Decline ≥ 50%
|
21.4 percentage of participants
Interval 4.7 to 50.8
|
41.7 percentage of participants
Interval 15.2 to 72.3
|
SECONDARY outcome
Timeframe: Up to 24 monthsAll participants will be evaluated for toxicity from the time of the first treatment with pembrolizumab. The number of participants with adverse events defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and categorized as having a possible, probable, or definite attribution to the administration of pembrolizumab from the start of treatment until 30 days after the end of treatment will be reported for each group.
Outcome measures
| Measure |
DNA Damage Repair Proficient Group
n=14 Participants
Participants with mismatch repair (MMR) intact receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
DNA Damage Repair Defective Group
n=12 Participants
Participants with defective DNA repair receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
|---|---|---|
|
Number of Participants Reporting Any Pembrolizumab Treatment-related Adverse Events
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: data on not collected
For participants who undergo taxane-based chemotherapy after progression on pembrolizumab followed by repeat pembrolizumab after chemotherapy, time from the first chemotherapy treatment to disease progression will be estimated in both study groups. Disease progression will be defined by confirmed PSA progression on two consecutive measurements at least 2 weeks apart, or radiographic progression by irRC. The Kaplan-Meier method will be used to estimate the median time to progression with 95% confidence interval by study group.
Outcome measures
Outcome data not reported
Adverse Events
DNA Damage Repair Proficient Group
Serious events: 1 serious events
Other events: 14 other events
Deaths: 8 deaths
DNA Damage Repair Defective Group
Serious events: 7 serious events
Other events: 12 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
DNA Damage Repair Proficient Group
n=14 participants at risk
Participants with mismatch repair (MMR) intact receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
DNA Damage Repair Defective Group
n=12 participants at risk
Participants with defective DNA repair receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pathologic femur fracture
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 2 • Up to 24 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/14 • Up to 24 months
|
16.7%
2/12 • Number of events 2 • Up to 24 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
1/14 • Number of events 2 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
7.1%
1/14 • Number of events 2 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
Other adverse events
| Measure |
DNA Damage Repair Proficient Group
n=14 participants at risk
Participants with mismatch repair (MMR) intact receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
DNA Damage Repair Defective Group
n=12 participants at risk
Participants with defective DNA repair receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. If disease worsens while receiving pembrolizumab, participants may receive standard of care chemotherapy for 2-8 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
50.0%
6/12 • Number of events 8 • Up to 24 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
8.3%
1/12 • Number of events 2 • Up to 24 months
|
|
Endocrine disorders
Hypothyroidism
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Eye disorders
Eye disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
25.0%
3/12 • Number of events 3 • Up to 24 months
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
2/14 • Number of events 3 • Up to 24 months
|
16.7%
2/12 • Number of events 2 • Up to 24 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14 • Up to 24 months
|
16.7%
2/12 • Number of events 3 • Up to 24 months
|
|
Gastrointestinal disorders
Nausea
|
28.6%
4/14 • Number of events 4 • Up to 24 months
|
16.7%
2/12 • Number of events 2 • Up to 24 months
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14 • Number of events 2 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/14 • Up to 24 months
|
16.7%
2/12 • Number of events 3 • Up to 24 months
|
|
General disorders
Edema limbs
|
14.3%
2/14 • Number of events 2 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
General disorders
Facial Pain
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
General disorders
Fatigue
|
64.3%
9/14 • Number of events 9 • Up to 24 months
|
50.0%
6/12 • Number of events 10 • Up to 24 months
|
|
General disorders
Pain
|
28.6%
4/14 • Number of events 6 • Up to 24 months
|
25.0%
3/12 • Number of events 5 • Up to 24 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
50.0%
7/14 • Number of events 11 • Up to 24 months
|
41.7%
5/12 • Number of events 10 • Up to 24 months
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 4 • Up to 24 months
|
16.7%
2/12 • Number of events 4 • Up to 24 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 2 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/14 • Up to 24 months
|
16.7%
2/12 • Number of events 2 • Up to 24 months
|
|
Investigations
Alkaline phosphatase increase
|
7.1%
1/14 • Number of events 2 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Investigations
Creatinine Increased
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Investigations
Weight loss
|
35.7%
5/14 • Number of events 5 • Up to 24 months
|
25.0%
3/12 • Number of events 3 • Up to 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
21.4%
3/14 • Number of events 3 • Up to 24 months
|
25.0%
3/12 • Number of events 3 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 2 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
8.3%
1/12 • Number of events 2 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/14 • Up to 24 months
|
16.7%
2/12 • Number of events 4 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
33.3%
4/12 • Number of events 4 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
28.6%
4/14 • Number of events 5 • Up to 24 months
|
25.0%
3/12 • Number of events 4 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
28.6%
4/14 • Number of events 9 • Up to 24 months
|
16.7%
2/12 • Number of events 3 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
2/14 • Number of events 2 • Up to 24 months
|
25.0%
3/12 • Number of events 4 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) -
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Nervous system disorders
Dysgeusia
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Number of events 2 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
8.3%
1/12 • Number of events 2 • Up to 24 months
|
|
Reproductive system and breast disorders
Pelvic Pain
|
7.1%
1/14 • Number of events 2 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14 • Up to 24 months
|
25.0%
3/12 • Number of events 3 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/14 • Up to 24 months
|
25.0%
3/12 • Number of events 3 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/14 • Up to 24 months
|
16.7%
2/12 • Number of events 2 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
7.1%
1/14 • Number of events 2 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
14.3%
2/14 • Number of events 2 • Up to 24 months
|
33.3%
4/12 • Number of events 5 • Up to 24 months
|
|
Vascular disorders
Hematoma
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • Number of events 1 • Up to 24 months
|
0.00%
0/12 • Up to 24 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/14 • Up to 24 months
|
8.3%
1/12 • Number of events 1 • Up to 24 months
|
Additional Information
Dr. David Oh, MD
University of California, San Francisco
Phone: (415) 476-1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place