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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-07-31

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.

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Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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veliparib (ABT-888)

Group Type EXPERIMENTAL

veliparib (ABT-888)

Intervention Type DRUG

Subjects will be given veliparib twice daily on Days 1-28 every 28 days orally.

Interventions

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veliparib (ABT-888)

Subjects will be given veliparib twice daily on Days 1-28 every 28 days orally.

Intervention Type DRUG

Other Intervention Names

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veliparib ABT-888

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No