Trial Outcomes & Findings for A Study of Olaparib and Durvalumab in Prostate Cancer (NCT NCT03810105)
NCT ID: NCT03810105
Last Updated: 2024-04-09
Results Overview
To assess the therapeutic efficacy as defined by an undetectable PSA (\<0.05 or PSA \<0.10 for institutions where this is the lower limit of detection) with non-castrate levels of testosterone using the combination olaparib (PARP inhibition) with durvalumab (PDL1 inhibition) at 24 months (cycle 24) in biochemically recurrent prostate cancer
TERMINATED
PHASE2
5 participants
1 year
2024-04-09
Participant Flow
Participant milestones
| Measure |
Castration Sensitive Biochemically Recurrent Prostate Cancer
Castration Sensitive Biochemically Recurrent Non-Metastatic Prostate Cancer
Olaparib: Olaparib 300mg twice daily (600mg total daily dose)
Durvalumab: Durvalumab 1500mg IV monthly
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Olaparib and Durvalumab in Prostate Cancer
Baseline characteristics by cohort
| Measure |
Castration Sensitive Biochemically Recurrent Prostate Cancer
n=5 Participants
Castration Sensitive Biochemically Recurrent Non-Metastatic Prostate Cancer
Olaparib: Olaparib 300mg twice daily (600mg total daily dose)
Durvalumab: Durvalumab 1500mg IV monthly
|
|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: N/A data were not collected
To assess the therapeutic efficacy as defined by an undetectable PSA (\<0.05 or PSA \<0.10 for institutions where this is the lower limit of detection) with non-castrate levels of testosterone using the combination olaparib (PARP inhibition) with durvalumab (PDL1 inhibition) at 24 months (cycle 24) in biochemically recurrent prostate cancer
Outcome measures
Outcome data not reported
Adverse Events
Castration Sensitive Biochemically Recurrent Prostate Cancer
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Castration Sensitive Biochemically Recurrent Prostate Cancer
n=5 participants at risk
Castration Sensitive Biochemically Recurrent Non-Metastatic Prostate Cancer
Olaparib: Olaparib 300mg twice daily (600mg total daily dose)
Durvalumab: Durvalumab 1500mg IV monthly
|
|---|---|
|
Investigations
Lymphocyte count decreased
|
100.0%
5/5 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
3/5 • 1 year
|
|
Investigations
Creatinine increased
|
60.0%
3/5 • 1 year
|
|
Investigations
Platelet count decreased
|
60.0%
3/5 • 1 year
|
|
Investigations
White blood cell decreased
|
60.0%
3/5 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
2/5 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
40.0%
2/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
40.0%
2/5 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
40.0%
2/5 • 1 year
|
|
Investigations
Activated partial thromboplastin time prolonged
|
20.0%
1/5 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
1/5 • 1 year
|
|
Investigations
Blood bilirubin increased
|
20.0%
1/5 • 1 year
|
|
Investigations
Cholesterol high
|
20.0%
1/5 • 1 year
|
|
Investigations
Hemoglobin increased
|
20.0%
1/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
20.0%
1/5 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
1/5 • 1 year
|
Additional Information
Dr. Karen Autio, MD
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place