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Poly(ADP-ribose) Polymerase Inhibitors

Rucaparib

Enzyme Inhibitors

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.

RUCAPARIB

Kim Reiss Binder, MD

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.

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

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 from initiation of rucaparib until death or last follow-up

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.

Confirmed complete response, partial response, or stable disease lasting for at least 16 weeks

Time from initial response to progression or death from any cause

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.

Abramson Cancer Center at Penn Medicine

Adverse events (AEs) were classified and graded according to the NCI Common Terminology Criteria of Adverse Events, version 4.1.

RUCAPARIB: Rucaparib was used as a maintenance therapy for eligible PDAC patients who received at least 16 weeks of platinum-based chemotherapy without evidence of platinum resistance. Chemotherapy was discontinued and patients received rucaparib 600 mg orally twice a day until progression.

Single Arm

RUCAPARIB: 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.

Age, Continuous

Sex: Female, Male

White Non-Hispanic

Black or African American

Asian

Hispanic or Latino

Race/Ethnicity, Customized

Mutations at baseline: gBRCA2, gBRCA1, gPALB2, sBRCA2.

Tumor histology

Disease stage at study start

4-6 months

6-12 months

More than 12 months

Less than 4 months

Platinum treatment duration

Patients had locally advanced or metastatic pancreatic cancer (neuroendocrine excluded); and had a confirmed pathogenic or likely pathogenic germline or somatic variant in BRCA1, BRCA2, or PALB2. Patients were required to have received at least 16 weeks of platinum-based chemotherapy for locally advanced or metastatic disease without evidence of platinum resistance.

Spots Global Cancer Trial Database for Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy

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