A Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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.) |
Drug: Rucaparib
Rucaparib will be administered twice daily
Other Names:
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Outcome Measures
Primary Outcome Measures
- Number of participants with treatment-related Adverse Events (AEs) as assessed by CTCAE v4.03 as a measure of safety and tolerability [From enrollment to completion of Part I (up to 12 months)]
- Number of participants with serious AEs as a measure of safety and tolerability [From enrollment to completion of Part I (up to 12 months)]
- Number of participants with worsening laboratory values as a measure of safety and tolerability [From enrollment to completion of Part I (up to 12 months)]
Secondary Outcome Measures
- Dose-limiting toxicities (DLTs) during Cycle 1 of treatment [From enrollment to completion of Part I (up to 12 months)]
- Area under the plasma concentration versus time curve [AUC] [From enrollment to completion of Part I (up to 12 months)]
- Peak Plasma Concentration [Cmax] [From enrollment to completion of Part I (up to 12 months)]
- Total Plasma Clearance [CI/F] [From enrollment to completion of Part I (up to 12 months)]
- Response to treatment according to RECIST Version 1.1 [From enrollment to primary completion of study (up to 3 years)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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).
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Have a solid tumor that has progressed on standard treatment:
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For patients enrolled in the dose-escalation portion, has confirmed solid tumor that is locally recurrent or metastatic
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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
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Have to have evaluable disease (i.e. disease can be followed on scans.)
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Be willing and able to fast for at least 14 hours
Exclusion Criteria:
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Active second malignancy
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Prior treatment with any PARP inhibitor
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Symptomatic and/or untreated CNS metastases
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Women who are breastfeeding or pregnant
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Pre-existing duodenal stent and/or any gastrointestinal disorder that would interfere with drug absorption
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Requires regular blood transfusions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Division of Medical Oncology, Hyogo Cancer Center | Akashi | Hyogo | Japan | 673-8558 |
| 2 | Department of Gynecologic Oncology, Saitama Medical Univeristy international Medical Center | Hidaka | Saitama | Japan | 350-1298 |
| 3 | Department of Breast and Medical Oncology, National Cancer Center Hospital | Tsukiji | Tokyo | Japan | 104-0045 |
Sponsors and Collaborators
- Clovis Oncology, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CO-338-081