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

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:

MedlinePlus related topics: Cancer

Drug Information available for: Carboplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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:	December 2013
Estimated Primary Completion Date:	August 2013 (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:

Subject must be 18 years of age.
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:	May 10, 2013
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 May 16, 2013