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

July 29, 2021 updated by: AbbVie (prior sponsor, Abbott)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the maximum tolerated dose and recommended Phase 2 dose
Time Frame: 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).
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

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics Area Under the Curve (AUC)
Time Frame: 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
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
Time Frame: Screening, Day 8 of each Cycle of drug and Final Visit
Screening, Day 8 of each Cycle of drug and Final Visit
Safety assessment: Clinical Laboratory Tests
Time Frame: Screening, Day 1 and Day 8 of each cycle, Final Visit and 30 Day Follow-up Visit
Hematology and Chemistry
Screening, Day 1 and Day 8 of each cycle, Final Visit and 30 Day Follow-up Visit
Physical exam including vital signs
Time Frame: 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
Screening, Cycle 1 Day 8, Day 1 of all cycles starting with Cycle2, Final Visit and 30 Day Follow-up Visit
Safety assessment: Adverse event assessments
Time Frame: All study visits
Collect all adverse events at each visit
All study visits
Tumor assessment
Time Frame: Screening, every nine weeks and Final Visit
Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden
Screening, every nine weeks and Final Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Investigators

  • Study Director: Mark D McKee, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

February 4, 2010

First Submitted That Met QC Criteria

February 4, 2010

First Posted (Estimate)

February 5, 2010

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 29, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-758

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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