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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rucaparib | Drug | Rucaparib will be administered twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Medical Oncology, Hyogo Cancer Center | Akashi | Hyōgo | 673-8558 | Japan | ||
| Department of Gynecologic Oncology, Saitama Medical Univeristy international Medical Center |
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| ID | Term |
|---|---|
| C531549 | rucaparib |
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| 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) |
| Hidaka |
| Saitama |
| 350-1298 |
| Japan |
| Department of Breast and Medical Oncology, National Cancer Center Hospital | Tsukiji | Tokyo | 104-0045 | Japan |