Trial Outcomes & Findings for Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer (NCT NCT03572478)
NCT ID: NCT03572478
Last Updated: 2021-03-09
Results Overview
Dose limiting toxicities (DLT) is measured by patients with grade 3 or 4 toxicity within 4 weeks of starting leading to discontinuation of rucaparib for at least 1 week
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
8 weeks
Results posted on
2021-03-09
Participant Flow
The study was terminated due to lack of efficacy such that participants were enrolled only in phase 1 cohort (single arm).
Participant milestones
| Measure |
Combination Therapy (Phase 1 Cohort)
Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.
Participants will receive rucaparib plus nivolumab in 4 week cycles.
Rucaparib: 600 mg taken by mouth twice daily.
Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks.
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer
Baseline characteristics by cohort
| Measure |
Combination Therapy (Phase 1 Cohort)
n=12 Participants
Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.
Participants will receive rucaparib plus nivolumab in 4 week cycles.
Rucaparib: 600 mg taken by mouth twice daily.
Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks.
|
|---|---|
|
Age, Continuous
|
72 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Two patients were not evaluable for DLT due to rapidly progressive disease.
Dose limiting toxicities (DLT) is measured by patients with grade 3 or 4 toxicity within 4 weeks of starting leading to discontinuation of rucaparib for at least 1 week
Outcome measures
| Measure |
Combination Therapy (Phase 1 Cohort)
n=10 Participants
Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.
Participants will receive rucaparib plus nivolumab in 4 week cycles.
Rucaparib: 600 mg taken by mouth twice daily.
Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks.
|
|---|---|
|
Percentage of Participants With Dose Limiting Toxicities (DLT) (Phase 1)
|
50 percentage of participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: No participants were enrolled in Phase 2 cohort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsPopulation: No participants were enrolled in Phase 2 cohort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsPopulation: No participants were enrolled in Phase 2 cohort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsPopulation: No participants were enrolled in Phase 2 cohort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 monthsPopulation: No participants were enrolled in Phase 2 cohort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: No participants were enrolled in Phase 2 cohort.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: No participants were enrolled in Phase 2 cohort.
Outcome measures
Outcome data not reported
Adverse Events
Combination Therapy (Phase 1 Cohort)
Serious events: 4 serious events
Other events: 12 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Combination Therapy (Phase 1 Cohort)
n=12 participants at risk
Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.
Participants will receive rucaparib plus nivolumab in 4 week cycles.
Rucaparib: 600 mg taken by mouth twice daily.
Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Gastrointestinal disorders
nausea
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Gastrointestinal disorders
vomiting
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Gastrointestinal disorders
diarrhea
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Metabolism and nutrition disorders
anorexia
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Nervous system disorders
neoplasms benign, malignant and unspecified
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Blood and lymphatic system disorders
anemia
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Renal and urinary disorders
acute kidney injury
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
General disorders
death
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
Other adverse events
| Measure |
Combination Therapy (Phase 1 Cohort)
n=12 participants at risk
Although we initially planned to conduct phase 1/2a study in the protocol, participants were enrolled only in phase 1 cohort.
Participants will receive rucaparib plus nivolumab in 4 week cycles.
Rucaparib: 600 mg taken by mouth twice daily.
Nivolumab: 480 mg given by intravenous (IV) infusion every 4 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
8/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Investigations
Alkaline phosphatase increased
|
41.7%
5/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
8/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
75.0%
9/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
2/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
8/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Investigations
Creatinine increased
|
16.7%
2/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Nervous system disorders
Dysgeusia
|
16.7%
2/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
General disorders
Edema limbs
|
16.7%
2/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Gastrointestinal disorders
Esophageal obstruction
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
General disorders
Fatigue
|
58.3%
7/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
16.7%
2/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Investigations
Lymphocyte count decreased
|
33.3%
4/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Investigations
Lymphocyte count increased
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Gastrointestinal disorders
Nausea
|
58.3%
7/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Investigations
Neutrophil count decreased
|
16.7%
2/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
General disorders
Pain
|
16.7%
2/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Investigations
Platelet count decreased
|
41.7%
5/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Investigations
Weight loss
|
33.3%
4/12 • Adverse event data were collected up to 28 days after the end of treatment
|
|
Investigations
White blood cell decreased
|
8.3%
1/12 • Adverse event data were collected up to 28 days after the end of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place