A Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor

A Phase 1, Open-label, Safety and Pharmacokinetic Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor

This is a Phase 1 open-label, dose-escalation, safety and pharmacokinetic study of rucaparib administered twice daily (BID) to Japanese patients with a solid tumor who have failed previous standard treatment for their cancer. A recommended dose of rucaparib for Japanese patients will be determined in a dose-escalation portion and then further evaluated in a dose-expansion portion of the study.

Inclusion Criteria:

• Be 20 years of age at the time the informed consent form is signed and of Japanese ethnicity (ie, both parents are native Japanese and were born in Japan).

• Have a solid tumor that has progressed on standard treatment:

  • For patients enrolled in the dose-escalation portion, has confirmed solid tumor that is locally recurrent or metastatic
  • For patients enrolled in the dose-expansion portion, has high-grade serous ovarian cancer, or BRCA 1/2 mutated breast cancer, or other solid tumor with BRCA 1/2 or related gene mutation

• Have to have evaluable disease (i.e. disease can be followed on scans.)

• Be willing and able to fast for at least 14 hours

Exclusion Criteria:

• Active second malignancy
• Prior treatment with any PARP inhibitor
• Symptomatic and/or untreated CNS metastases
• Women who are breastfeeding or pregnant
• Pre-existing duodenal stent and/or any gastrointestinal disorder that would interfere with drug absorption
• Requires regular blood transfusions