Description:
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.
Title
- Brief Title: A Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor
- Official Title: A Phase 1, Open-label, Safety and Pharmacokinetic Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor
Clinical Trial IDs
- ORG STUDY ID:
CO-338-081
- NCT ID:
NCT03499444
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Rucaparib | CO-338 | Oral Rucaparib monotherapy |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Oral Rucaparib monotherapy | Experimental | 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.) | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 20 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Number of participants with treatment-related Adverse Events (AEs) as assessed by CTCAE v4.03 as a measure of safety and tolerability |
Time Frame: | From enrollment to completion of Part I (up to 12 months) |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Dose-limiting toxicities (DLTs) during Cycle 1 of treatment |
Time Frame: | From enrollment to completion of Part I (up to 12 months) |
Safety Issue: | |
Description: | |
Measure: | Area under the plasma concentration versus time curve [AUC] |
Time Frame: | From enrollment to completion of Part I (up to 12 months) |
Safety Issue: | |
Description: | |
Measure: | Peak Plasma Concentration [Cmax] |
Time Frame: | From enrollment to completion of Part I (up to 12 months) |
Safety Issue: | |
Description: | |
Measure: | Total Plasma Clearance [CI/F] |
Time Frame: | From enrollment to completion of Part I (up to 12 months) |
Safety Issue: | |
Description: | |
Measure: | Response to treatment according to RECIST Version 1.1 |
Time Frame: | From enrollment to primary completion of study (up to 3 years) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Clovis Oncology, Inc. |
Last Updated
August 11, 2021