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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01063816
First Posted: February 5, 2010
Last Update Posted: August 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
February 4, 2010
February 5, 2010
August 25, 2016
January 2010
August 2016   (Final data collection date for primary outcome measure)
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). ]
Determine the maximum tolerated dose and recommended Phase 2 dose [ Time Frame: Screening to final study visit ]
Complete list of historical versions of study NCT01063816 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Safety assessment: Electrocardiogram [ Time Frame: 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
  • 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
  • Safety assessment: Adverse event assessments [ Time Frame: All study visits ]
    Collect all adverse events at each visit
  • Tumor assessment [ Time Frame: Screening, every nine weeks and Final Visit ]
    Computerized tomography (CT) scan of chest, abdomen and pelvis to assess tumor burden
  • Pharmacokinetics of ABT-888 when given in combination with carboplatin and gemcitabine [ Time Frame: Cycle 1 through Cycle 4 ]
  • Safety assessments (i.e. ECG, clinical laboratory tests, vital signs, adverse events assessments, physical exams, CT scans) [ Time Frame: Screening through final visit ]
Not Provided
Not Provided
 
A Study of ABT-888 in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Solid Tumors
  • 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
Experimental: Arm 1
Interventions:
  • Drug: veliparib (ABT-888)
  • Drug: carboplatin
  • Drug: gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
August 2016
August 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01063816
M10-758
No
Not Provided
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Mark D McKee, MD AbbVie
AbbVie
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP