Skip to main content
OpenTrials
Completed

NCT Number: NCT01063816

A Study of ABT-888 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Solid Tumors

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

veliparib (ABT-888)

Drug

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

carboplatin

Drug

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

Gemcitabine

Drug

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

Other names: Gemzar

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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

  2. Safety assessment: Electrocardiogram

    Time frame: Screening, Day 8 of each Cycle of drug and Final Visit

  3. 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

  4. 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

  5. Safety assessment: Adverse event assessments

    Time frame: All study visits

    Collect all adverse events at each visit

  6. Tumor assessment

    Time frame: Screening, every nine weeks and Final Visit

    Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Feb 5, 2010
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.