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

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: veliparib (ABT-888); Drug: carboplatin; Drug: gemcitabine

• Registration Number: NCT01063816
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-05
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-29
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	veliparib (ABT-888)	-
Arm 1	carboplatin	-
Arm 1	gemcitabine	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Safety assessment: Adverse event assessments	All study visits	Collect all adverse events at each visit
Safety assessment: Electrocardiogram	Screening, Day 8 of each Cycle of drug and Final Visit
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
Tumor assessment	Screening, every nine weeks and Final Visit	Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden
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