A Study of ABT-888 in Combination With Carboplatin and Gemcitabine in 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

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2016-08-31

Brief Summary

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The purpose of this study is to determine the maximum tolerated dose of veliparib (ABT-888)and to establish the recommended Phase 2 dose of veliparib (ABT-888) when administered in combination with carboplatin and gemcitabine in 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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Arm 1

Group Type EXPERIMENTAL

veliparib (ABT-888)

Intervention Type DRUG

Dosing orally twice daily starting Cycle 2 Day 1- through 21 adjusted for subsequent cohorts using a continuous reassessment method.

carboplatin

Intervention Type DRUG

Carboplatin will be dosed on Day 1 of each cycle, intravenously.

gemcitabine

Intervention Type DRUG

Dosing on Days 1 and 8 of each Cycle, intravenously.

Interventions

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veliparib (ABT-888)

Dosing orally twice daily starting Cycle 2 Day 1- through 21 adjusted for subsequent cohorts using a continuous reassessment method.

Intervention Type DRUG

carboplatin

Carboplatin will be dosed on Day 1 of each cycle, intravenously.

Intervention Type DRUG

gemcitabine

Dosing on Days 1 and 8 of each Cycle, intravenously.

Intervention Type DRUG

Other Intervention Names

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Gemzar

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed solid tumors that are metastatic or unrespectable for which carboplatin/gemcitabine is a treatment option.
* Eastern Cooperative Group performance score of 0 to 2.
* Adequate hematologic, hepatic and renal function
* Subject has received up to 2 DNA damaging or cytotoxic regimens in the past five years

Exclusion Criteria

* Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational therapy within 28 days prior to study administration.
* Subjects with known history of brain metastases and primary CNS tumors.
* Hypersensitivity reactions to platinum compounds or gemcitabine.
* Clinically significant and uncontrolled major medical conditions
* Active malignancy within the past 5 years except for any cancer in situ cured or non-melanoma carcinoma of the skin.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No