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A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients With a Solid Tumor or With gBRCA Mutation Ovarian Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

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Trial Information

A Phase I/II, Open-Label, Safety, Pharmacokinetic, and Preliminary Efficacy Study of Oral Rucaparib in Patients With a Solid Tumor or With gBRCA Mutation Ovarian Cancer

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.

Inclusion Criteria:

(PART 1)

- All cohorts (Dose Escalation and R2PD expansion): Adequate bone marrow, hepatic
(liver), renal, and cardiac function.

- All cohorts: Locally recurrent or metastatic solid tumor (includes lymphoma) that has
progressed on standard treatment.

- R2PD Expansion cohort only: Documented deleterious gBRCA mutation.


(PART 2)

- Ovarian cancer associated with a gBRCA mutation that has relapsed >6 months
following prior platinum-based prior treatment and is measurable. Two to four prior
treatment regimens permitted.

Exclusion Criteria:


- History of prior cancer except for non-melanoma skin cancer, curatively treated solid
tumor (>5 years ago without evidence of recurrence), and synchronous endometrial
cancer (Stage 1A) with ovarian cancer.

- Prior treatment with any PARP inhibitor, including rucaparib. Patients who received
prior iniparib are eligible.

- Untreated or symptomatic central nervous system metastases.

- Impaired cardiac function or clinically significant cardiac disease.

- Prior gastrectomy or upper bowel removal or any gastrointestinal disorder that would
interfere with the absorption of rucaparib.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Grade 3 or 4 adverse events and clinical lab abnormalities defined as DLTs (Part 1)

Outcome Time Frame:

Cycle 1 Days 1, 8, 15 and 22

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • gBRCA ovarian cancer
  • platinum sensitive
  • PARP Inhibitor
  • Rucaparib
  • CO-338
  • PF 01367338
  • AG 14699
  • BRCA1
  • BRCA2
  • platinum sensitive ovarian cancer
  • platinum sensitive gBRCA ovarian cancer
  • gynecological cancer
  • relapsed disease
  • homologous recombination deficiency
  • HRD
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Karmanos Cancer InstituteDetroit, Michigan  48201
Sarah Cannon Research InstituteNashville, Tennessee  37203
Sarah Cannon Research InstituteSarasota, Florida  34232