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

Sponsor

AbbVie (prior sponsor, Abbott) (Industry)

Overall Status

Completed

CT.gov ID

NCT01063816

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Drug: veliparib (ABT-888) Drug: carboplatin Drug: gemcitabine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

79 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1 Study of Veliparib in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: veliparib (ABT-888) Dosing orally twice daily starting Cycle 2 Day 1- through 21 adjusted for subsequent cohorts using a continuous reassessment method. Drug: carboplatin Carboplatin will be dosed on Day 1 of each cycle, intravenously. Drug: gemcitabine Dosing on Days 1 and 8 of each Cycle, intravenously. Other Names: Gemzar

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: veliparib (ABT-888)

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

Drug: carboplatin

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

Drug: gemcitabine

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

Other Names:

Gemzar

Outcome Measures

Primary Outcome Measures

Determine the maximum tolerated dose and recommended Phase 2 dose [ABT-888 will be dose escalated until the largest dose is reached based on the probability of dose, limiting toxicities is based per continual reassessment method (CRM).]

Secondary Outcome Measures

Pharmacokinetics Area Under the Curve (AUC) [Timepoints: 30 and 45 minutes, 1,1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5,6,6.5, 7 and 8 hours past dose]
Safety assessment: Electrocardiogram [Screening, Day 8 of each Cycle of drug and Final Visit]
Safety assessment: Clinical Laboratory Tests [Screening, Day 1 and Day 8 of each cycle, Final Visit and 30 Day Follow-up Visit]
Hematology and Chemistry
Physical exam including vital signs [Screening, Cycle 1 Day 8, Day 1 of all cycles starting with Cycle2, Final Visit and 30 Day Follow-up Visit]
Physical exam including blood pressure, pulse and temperature
Safety assessment: Adverse event assessments [All study visits]
Collect all adverse events at each visit
Tumor assessment [Screening, every nine weeks and Final Visit]
Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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.