Pancreatic Cancer Research

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.