A Study of ABT-888 in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors

AbbVie

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: gemcitabine

Drug: veliparib (ABT-888)

Drug: carboplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01063816

M10-758

Details and patient eligibility

About

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.

Enrollment

79 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.