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

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.

OR

(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:

(ALL)

- 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.