Clinical trialPhase 2Terminated
Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy
A Phase 2, Open Label Study of Rucaparib in Patients With Advanced Pancreatic Cancer and a Known Deleterious Germline or Somatic BRCA or PALB2 Mutation
- Outcome
- Stopped earlyLoss of funding (Business decision)
- Phase
- Phase 2
- Status
- Terminated
- Study type
- Interventional
- Start
- 5 September 2017
- Expected end
- 7 August 2023
- Enrollment
- 46 participants
- Sites
- 1
- Primary outcomes
- Progression-Free Survival (PFS) at 6 Months (PFS6)
- Sponsor
- Other
- Results posted
- 2023-09-28
- Last update
- 28 September 2023
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Brief summary public domain (ClinicalTrials.gov)
The main purpose of this study is to look at the effectiveness, safety, and antitumor activity (preventing growth of the tumor) of the experimental study drug rucaparib (also known as CO-338) on subjects and on their pancreatic cancer.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Progression-Free Survival (PFS) at 6 Months (PFS6) [6 months]. Number, Percentage of participants (95% Confidence Interval). Single Arm (n=42): 59.5 (44.6 to 74.4).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival [24 months]. Median, Months (95% Confidence Interval). Single Arm (n=42): 23.5 (20 to 27).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Response Rate (ORR) [24 months]. Number, Percentage of participants (95% Confidence Interval). Single Arm (n=36): 41.7 (25.5 to 59.2).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Disease Control Rate (DCR) [24 months]. Number, Percentage of evaluable patients (95% Confidence Interval). Single Arm (n=36): 66.7 (49 to 81.4).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Duration of Response (DOR) [24 months]. Median, Months (95% Confidence Interval). Single Arm (n=36): 17.3 (8.8 to 25.8).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Toxicity at Least Possibly Related to Rucaparib [24 months]. Number, Percentage of participants. Anemia: Single Arm (n=46): 74. Nausea: Single Arm (n=46): 48. Increased ALT: Single Arm (n=46): 47. Fatigue: Single Arm (n=46): 45. Thrombocytopenia: Single Arm (n=46): 39. Dysgeusia: Single Arm (n=46): 37.
Papers 2
- Builds on itThe Clinical Implications of Reversions in Patients with Advanced Pancreatic Cancer and Pathogenic Variants in BRCA1, B… DOI 10.1158/1078-0432.ccr-23-1467↗
- Builds on itPhase II Study of Maintenance Rucaparib in Patients With Platinum-Sensitive Advanced Pancreatic Cancer and a Pathogenic… DOI 10.1200/jco.21.00003↗