A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors

Study Overview
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Brief Summary
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This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid tumors.

Official Title
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A Phase 1 Study of Single Agent Veliparib in Japanese Subjects With Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: veliparib (ABT-888)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed malignant solid tumor, and any of the following: * Subjects with recurrent high grade serous ovarian cancer who completed or discontinued platinum based therapy; * Subjects with BRCA-mutated breast cancer who have received prior chemotherapy with anthracycline and/or taxanes; * Subjects with deleterious mutations of BRCA with advanced solid tumors who have received available standard therapies. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Life expectancy of greater than 12 weeks. Adequate organ and marrow function· Measurable or non-measurable disease. Exclusion Criteria: Major surgery and/or radiation within (<) 4 weeks prior to study enrollment. Chemotherapy or hormone therapy within (<) 4 weeks prior to study enrollment except for mitomycin C and nitrosoureas, in which case it is 6 weeks. Any investigational agents within (<) 4 weeks prior to study enrollment. Any anti-cancer Chinese medicine/herbal remedies within 14 days prior to study enrollment. Toxicities (with the exception of alopecia) from prior major surgery, radiation, or systemic chemotherapy have not recovered to less than grade 2.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 99 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: veliparib (ABT-888)<br> | Drug: veliparib (ABT-888)<br>* Subjects will be given veliparib twice daily on Days 1-28 every 28 days orally.<br>* Other names: ABT-888;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-limiting toxicities of veliparib |  | During the first cycle (28 days) of veliparib administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in participant physical exam measurements | Blood pressure, pulse and body temperature | Approximately 1 year | 
| Change in participant clinical lab results | Hematology, Chemistry and Urinalysis | Approximately 1 year | 
| Number of participants with adverse events | Collect all adverse events at each visit and assess according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03 | Approximately 1 year | 
| Preliminary tumor response | According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 | Participants will be followed for the duration of an expected average of 8 months. | 
| Maximum observed plasma concentration (Cmax) | Maximum observed concentration, occurring at Tmax | For 24 hours following veliparib dosing. | 
| The time to Cmax (peak time, Tmax) | The time at which maximum plasma concentration (Cmax) is observed. | For 24 hours following veliparib dosing. | 
| The area under the plasma concentration-time curve (AUC) |  | For 24 hours following veliparib dosing. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, PARP, Primary peritoneal cancer, Fallopian tube, Ovarian cancer, veliparib, ABT-888, BRCA