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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01063816
First received: February 4, 2010
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to determine the maximum tolerated dose and establish the recommended Phase 2 dose of ABT-888 when administered in combination with carboplatin and gemcitabine in subjects with advanced solid tumors.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Safety assessment: Electrocardiogram [ Time Frame: Screening, Day 8 of each Cycle of drug and Final Visit ] [ Designated as safety issue: Yes ]
  • Safety assessment: Clinical Laboratory Tests [ Time Frame: Screening, Day 1 and Day 8 of each cycle, Final Visit and 30 Day Follow-up Visit ] [ Designated as safety issue: Yes ]
    Hematology and Chemistry

  • 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 ] [ Designated as safety issue: Yes ]
    Physical exam including blood pressure, pulse and temperature

  • Safety assessment: Adverse event assessments [ Time Frame: All study visits ] [ Designated as safety issue: Yes ]
    Collect all adverse events at each visit

  • Tumor assessment [ Time Frame: Screening, every nine weeks and Final Visit ] [ Designated as safety issue: No ]
    Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden


Estimated Enrollment: 85
Study Start Date: January 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Gemzar

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01063816

Locations
United States, California
Site Reference ID/Investigator# 23283
Duarte, California, United States, 91010
Site Reference ID/Investigator# 27743
Duarte, California, United States, 91010
United States, Illinois
Site Reference ID/Investigator# 23284
Chicago, Illinois, United States, 60637-1470
United States, New York
Site Reference ID/Investigator# 23282
New York, New York, United States, 10065
United States, Pennsylvania
Site Reference ID/Investigator# 23286
Philadelphia, Pennsylvania, United States, 19111
United States, Washington
Site Reference ID/Investigator# 23285
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Mark D McKee, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01063816     History of Changes
Other Study ID Numbers: M10-758
Study First Received: February 4, 2010
Last Updated: February 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
PARP Inhibitors

Additional relevant MeSH terms:
Neoplasms
Gemcitabine
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on April 17, 2014