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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Open-label, Safety and Pharmacokinetic Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: Rucaparib


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Rucaparib monotherapy<br>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<br>* Rucaparib will be administered twice daily<br>* Other names: CO-338;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |