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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Rucaparib is a PARP inhibitor used as an anti-cancer agent. Rucaparib is a first-in-class pharmaceutical drug targeting the DNA repair enzyme poly-ADP ribose polymerase-1.
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Progression-Free Survival (PFS) at 6 Months (PFS6)
Time from initiation of rucaparib until progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Only if absolute increase is equal to or greater than 5mm.
Time frame: 6 months
Overall Survival
Time from initiation of rucaparib until death or last follow-up
Time frame: 24 months
Overall Response Rate (ORR)
Confirmed Complete Response or Partial Response according to RECIST v1.1. Complete Response (CR) is defined as tumor burden reduced to 0.0 mm or lymph node lesions are smaller than 10mm. Partial Response (PR), tumor burden decreased by greater than 30% but not CR. Overall Response Rate (ORR) is defined as confirmed CR or PR.
Time frame: 24 months
Disease Control Rate (DCR)
Confirmed complete response, partial response, or stable disease lasting for at least 16 weeks
Time frame: 24 months
Duration of Response (DOR)
Time from initial response to progression or death from any cause
Time frame: 24 months
Toxicity at Least Possibly Related to Rucaparib
Toxicity of rucaparib as maintenance therapy was assessed by examining Adverse Events (AEs) that were at least possibly related to the drug treatment. AEs were classified and graded according to the NCI Common Terminology Criteria of Adverse Events, version 4.1.
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Time frame: 24 months