Back to resultsA Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation
Primary Purpose
Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Rucaparib
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring BRCA, BRCA mutation, germline BRCA, somatic BRCA, PARP inhibitor, rucaparib, CO-338, PF 01367338, AG 14699, Clovis, Clovis Oncology, RucaPanc
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Cedars Sinai Medical Center
- Mayo Clinic
- New York University
- University of Pennsylvania
- MD Anderson Cancer Center
- Rambam Healthcare Campus
- Hadassah Hebrew University Hospital (Sharett Institute of Oncology)
- Tel Aviv Sourasky Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rucaparib
Arm Description
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.
Outcomes
Primary Outcome Measures
Overall Response Rate (ORR) per RECIST v1.1 as assessed by the investigator
Secondary Outcome Measures
Overall Response Rate (ORR) per RECIST v1.1 as assessed by independent radiology review
Duration of Response (DOR) by RECIST v1.1
PFS defined as the occurrence of disease progression according to RECIST v1.1, as assessed by the investigator, or death from any cause
Overall Survival (OS)
Incidence of adverse events (AEs), clinical laboratory abnormalities, and dose modifications
Trough (Cmin) level rucaparib concentrations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02042378
Brief Title
A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation
Official Title
A Phase 2, Open-Label Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
pharmaand GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) that inhibits a specific DNA repair pathway known as base excision repair (BER). PARP inhibitors (PARPi) have been shown to effectively kill tumors with a defect in BRCA1 or BRCA2. Clinical benefit has been observed in patients with a gBRCA mutation as well as in those with a somatic BRCA (sBRCA) mutation. Clinical data have also shown that pancreatic cancer patients with a gBRCA mutation benefit from PARPi treatment. Clinical activity of PARP inhibitors in BRCA-mutated pancreatic cancer combined with the paucity of 2nd line therapies support evaluation of rucaparib in pancreatic cancer patients known to harbor a deleterious BRCA mutation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rucaparib
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rucaparib
Other Intervention Name(s)
CO-338, PF 01367338, AG 14699
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) per RECIST v1.1 as assessed by the investigator
Time Frame
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 Outcome Measure Information:
Title
Overall Response Rate (ORR) per RECIST v1.1 as assessed by independent radiology review
Time Frame
Screening, within 7 days prior to the start of every 3rd cycle of treatment, and Treatment Discontinuation Visit. Study to last for ~3 years.
Title
Duration of Response (DOR) by RECIST v1.1
Time Frame
Screening, within 7 days prior to the start of every 3rd cycle of treatment, and Treatment Discontinuation Visit. Study to last for ~3 years.
Title
PFS defined as the occurrence of disease progression according to RECIST v1.1, as assessed by the investigator, or death from any cause
Time Frame
Screening, within 7 days prior to the start of every 3rd cycle of treatment, and Treatment Discontinuation Visit. Study to last for ~3 years.
Title
Overall Survival (OS)
Time Frame
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.
Title
Incidence of adverse events (AEs), clinical laboratory abnormalities, and dose modifications
Time Frame
Continuously from signing of informed consent to 28 days after the last dose. Study to last for ~3 years.
Title
Trough (Cmin) level rucaparib concentrations
Time Frame
Cycle 1 Day 15, Cycle 2 Day 15, Cycle 3 Day 1, and Cycle 4 Day 1. Study to last for ~3 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Giordano
Organizational Affiliation
Clovis Oncology, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10012
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Rambam Healthcare Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Hebrew University Hospital (Sharett Institute of Oncology)
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation
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