Part 1 (Completed Enrollment) - The purpose of the first part of the study was to evaluate
the safety of different doses and dosing regimens of oral rucaparib administered daily to
patients with solid tumors.
Part 2A (Completed Enrollment) and Part 2B (Currently Enrolling) - The purpose of the second
part of the study is to determine the safety and clinical activity of the RP2D of oral
rucaparib administered daily to patients with a known deleterious BRCA mutation (germline or
Part 3 (Currently Enrolling) - The purpose of the third part of the study is to further
evaluate PK of higher dose strength tablets at the RP2D in patients with any advanced solid
tumor, inclusive of lymphoma, with evidence of a BRCA mutation (germline or somatic).
Rucaparib (CO-338; formerly known as PF 01367338 and AG 14699) is an orally available, small
molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) being
developed for treatment of ovarian cancer associated with homologous recombination [HR] DNA
repair deficiency (HRD). The safety and efficacy of rucaparib has been evaluated in several
Phase 1 and Phase 2 studies.
An oral formulation is the focus of current development efforts. Rucaparib is currently
being investigated as monotherapy in patients with cancer associated with BRCA1 or BRCA2
mutations. For this study, it is anticipated that rucaparib will promote cell death in the
BRCA-deficient tumor cells of ovarian cancer patients with evidence of a germline mutation,
thereby limiting tumor progression and providing therapeutic benefit.
Phase 1/Phase 2
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Drug : Rucaparib
Study Arm Groups : Oral Rucaparib monotherapy
See Interventions above
- Incidence of Grade 3 or 4 adverse events and clinical lab abnormalities defined as DLTs (Part 1); Cycle 1 Days 1, 8, 15 and 22; PK Profile for Single Dose and at Steady State (Part 1 and Part 3 only); Days 1 and 15 of Cycle 1; Overall Response Rate per RECIST version 1.1 (Part 2); Every 2 - 3 cycles of treatment
- PK profile (fasted and fed) (Part 1 and PART 3 only); Day -7 and Day 1 of Cycle 1; Change from baseline in QT/QTc interval (ECG) (Part 1 only); Every week (Cycle 1); q3wks (Cycles 2+); Incidence of AEs, clinical laboratory abnormalities, and ECG abnormalities (Part 1, 2, and 3); Every 1-2 weeks (Cycle 1); q3wks (Cycles 2+); Duration of response per RECIST version 1.1 (Part 2 only); Every 2-3 cycles of treatment; Response per RECIST version 1.1 (Part 1 only); Every 2-3 cycles of treatment; Overall Survival (Part 2B); study data collection expected to last for ~ 2 years
Sorry, this information is not available
This is available on the Clinicaltrials.gov
18 Years - N/A
- The following eligibility criteria below pertain to patients enrolling into Part 2B or
- Part 3 of the study.
- Inclusion Criteria:
- - Have a known deleterious BRCA mutation (gBRCA or sBRCA) (as determined by a local
- laboratory that has received an international or country-specific, quality standards
- - Have evidence of measurable disease as defined by RECIST Version 1.1
- - Have sufficient archival FFPE tumor tissue available for planned analyses.
- - Archival tissue from the most recently collected biopsy or debulking surgery should
- be provided, if available.
- - Have a histologically confirmed diagnosis of high-grade epithelial ovarian, fallopian
- tube, or primary peritoneal cancer (Part 2B only).
- - Have received at least three prior chemotherapy regimens and have relapsed disease
- confirmed by radiologic assessment (Part 2B only).
- - Have an advanced solid tumor, inclusive of lymphoma (Part 3 only).
- - Be willing and able to fast, and to eat a high-fat breakfast on Day -7 or Day 1 of
- the study (Part 3 only).
- Exclusion Criteria:
- - Active second malignancy, i.e., patient known to have potentially fatal cancer
- present for which she may be (but not necessarily) currently receiving treatment
- a. Patients with a history of malignancy that has been completely treated, with no
- evidence of that cancer currently, are permitted to enroll in the trial provided all
- chemotherapy was completed >6 months prior and/or bone marrow transplant (BMT) >2
- years prior to first dose of rucaparib
- - Prior treatment with any PARP inhibitor (Part 1, Part 2). Part 3 patients are
- permitted to have had previous PARPi, if the following conditions are met:
- - PARPi was not the most recent treatment, and
- - PARPi was discontinued >6 months before first planned dose of rucaparib In all study
- parts, patients who previously received iniparib are eligible
- - Untreated or symptomatic central nervous system (CNS) metastases. Patients with
- asymptomatic CNS metastases are eligible provided they have been clinically stable
- for at least 4 weeks.
- - Received treatment with chemotherapy, radiation, antibody therapy or other
- immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or
- experimental drugs 14 days prior to first dose of rucaparib and/or ongoing adverse
- effects from such treatment > NCI CTCAE Grade 1 (Grade 2 non-hematologic toxicity to
- most recent treatment may be permitted with prior advanced approval from Sponsor).
- - Hospitalization for bowel obstruction within 3 months prior to enrollment (Part 2B
This is in the inclusion criteria above
A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients With gBRCA Mutation Ovarian Cancer or Other Solid Tumor
Not available for this trial
Sorry, this information is not available
Clovis Oncology, Inc.