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

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Carboplatin; Gemcitabine; Veliparib

Criteria

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.