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

NCT ID: NCT03499444

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-06
• Study Completion Date: 2022-04-13

Brief Summary

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.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral Rucaparib monotherapy

Part I: Dose Escalation, Part II: Dose Expansion (Additional patients will be enrolled at the recommended dose as defined in Part I of the study.)

Group Type: EXPERIMENTAL

Rucaparib

Intervention Type: DRUG

Rucaparib will be administered twice daily

Interventions

Rucaparib

Rucaparib will be administered twice daily

Intervention Type: DRUG

Other Intervention Names

CO-338

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

pharmaand GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Medical Oncology, Hyogo Cancer Center

Akashi, Hyōgo, Japan

Department of Gynecologic Oncology, Saitama Medical Univeristy international Medical Center

Hidaka, Saitama, Japan

Department of Breast and Medical Oncology, National Cancer Center Hospital

Tsukiji, Tokyo, Japan

Countries

Japan

Other Identifiers

CO-338-081

Identifier Type: -

Identifier Source: org_study_id