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

pharmaand

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumor

Treatments

Drug: Rucaparib

Study type

Interventional

Funder types

Industry

Identifiers

NCT03499444

CO-338-081

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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