A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation

NCT02042378 | Completed Phase 2 DMC

• 1 other identifier: CO-338-023
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 8

Brief Summary

The purpose of this study is to determine whether oral rucaparib is effective in the treatment of patients with locally advanced or metastatic pancreatic cancer and a known deleterious BRCA mutation.

Conditions

Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma

Keywords

BRCA; BRCA mutation; germline BRCA; somatic BRCA; PARP inhibitor; rucaparib; CO-338; PF 01367338; AG 14699; Clovis; Clovis Oncology; RucaPanc

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) per RECIST v1.1 as assessed by the investigator

  Screening, within 7 days prior to the start of every 3rd cycle of treatment, and Treatment Discontinuation Visit. Study to last for ~3 years.

Secondary Outcomes (6)

• Overall Response Rate (ORR) per RECIST v1.1 as assessed by independent radiology review

  Screening, within 7 days prior to the start of every 3rd cycle of treatment, and Treatment Discontinuation Visit. Study to last for ~3 years.

• Duration of Response (DOR) by RECIST v1.1

  Screening, within 7 days prior to the start of every 3rd cycle of treatment, and Treatment Discontinuation Visit. Study to last for ~3 years.

• PFS defined as the occurrence of disease progression according to RECIST v1.1, as assessed by the investigator, or death from any cause

  Screening, within 7 days prior to the start of every 3rd cycle of treatment, and Treatment Discontinuation Visit. Study to last for ~3 years.

• Overall Survival (OS)

  To be performed continually from first dose of study drug through discontinuation, then every 4 weeks until death, loss to follow-up, withdrawal of consent from study, or closure of the study. Study to last for ~3 years.

• Incidence of adverse events (AEs), clinical laboratory abnormalities, and dose modifications

  Continuously from signing of informed consent to 28 days after the last dose. Study to last for ~3 years.

Study Arms (1)

Rucaparib

EXPERIMENTAL

All patients will take oral tablets twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.

Drug: Rucaparib

Interventions

Rucaparib DRUG

All patients will take oral tablets twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.

Also known as: CO-338, PF 01367338, AG 14699

Rucaparib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of pancreatic cancer (ductal adenocarcinoma and related subtypes eligible; endocrine and neuroendocrine tumors excluded)
• Received at least 1, but no more than 2, chemotherapy-based regimens for locally advanced or metastatic disease and has relapsed or progressive disease. Patients no longer able to continue treatment with chemotherapy due to intolerable toxicity may be considered for study participation provided that radiology assessment confirms either stable disease or disease progression (i.e. no response to treatment)
• Documented deleterious or suspected deleterious (or equivalent interpretation) BRCA mutation (germline or somatic) as assessed by a local laboratory
• Measurable disease

You may not qualify if:

• Presence of another active cancer
• Prior treatment with any PARP inhibitor, including rucaparib. Patients treated with prior iniparib are eligible.
• Symptomatic and/or untreated central nervous system metastases.
• Clinical evidence of malabsorption and/or any other gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with the absorption of rucaparib.

Sponsors & Collaborators

• pharmaand GmbH: lead

Study Sites (8)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

New York University

New York, New York, 10012, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Rambam Healthcare Campus

Haifa, 31096, Israel

Location

Hadassah Hebrew University Hospital (Sharett Institute of Oncology)

Jerusalem, 91120, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

rucaparib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Heidi Giordano

  Clovis Oncology, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2014
• First Posted: January 22, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

US (5); IL (3)