ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients

Rucaparib 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 breast cancer susceptibility gene 1
(BRCA1) or BRCA2 mutations.

While PARP inhibitors have demonstrated consistent robust clinical activity in patients with
relapsed ovarian cancer associated with HRD, prospective studies evaluating efficacy and
safety of PARPi versus standard of care chemotherapy have been limited. The primary purpose
of this Phase 3 study is to compare the efficacy and safety of rucaparib versus chemotherapy
as treatment for relapsed ovarian cancer in patients with a deleterious BRCA1/2 mutation in
their tumor.

Inclusion Criteria:

- Be 18 years of age at the time the informed consent form is signed

- Have a histologically confirmed diagnosis of high-grade serous or Grade 2 or Grade 3
endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer

- Received ≥ 2 prior chemotherapy regimens and have relapsed or progressive disease as
confirmed by radiologic assessment

- Have biopsiable and evaluable disease. Note: biopsy is optional for patients known to
harbor a BRCA1/2 mutation

- Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue
available for planned analyses

Exclusion Criteria:

- History of prior cancers except for those that have been curatively treated, with no
evidence of cancer currently (provided all chemotherapy was completed >6 months prior
and/or bone marrow transplant >2 years prior to first dose of rucaparib).

- Prior treatment with any PARP inhibitor

- Symptomatic and/or untreated central nervous system metastases

- Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that
would, in the opinion of the Investigator, interfere with absorption of rucaparib

- Women who are pregnant or breast feeding

- Hospitalization for bowel obstruction within 3 months prior to enrollment