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

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ClinicalTrials.gov Identifier: NCT01063816
Recruitment Status : Completed
First Posted : February 5, 2010
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Tracking Information
First Submitted Date  ICMJE February 4, 2010
First Posted Date  ICMJE February 5, 2010
Last Update Posted Date August 2, 2021
Study Start Date  ICMJE January 2010
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
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). ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
Determine the maximum tolerated dose and recommended Phase 2 dose [ Time Frame: Screening to final study visit ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2010)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ABT-888 in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors
Official Title  ICMJE A Phase 1 Study of Veliparib in Combination With Carboplatin and Gemcitabine in Subjects With Advanced Solid Tumors
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Arm 1
Interventions:
  • Drug: veliparib (ABT-888)
  • Drug: carboplatin
  • Drug: gemcitabine
Publications * Gray HJ, Bell-McGuinn K, Fleming GF, Cristea M, Xiong H, Sullivan D, Luo Y, McKee MD, Munasinghe W, Martin LP. Phase I combination study of the PARP inhibitor veliparib plus carboplatin and gemcitabine in patients with advanced ovarian cancer and other solid malignancies. Gynecol Oncol. 2018 Mar;148(3):507-514. doi: 10.1016/j.ygyno.2017.12.029. Epub 2018 Jan 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2016)
79
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2010)
60
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01063816
Other Study ID Numbers  ICMJE M10-758
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AbbVie ( AbbVie (prior sponsor, Abbott) )
Study Sponsor  ICMJE AbbVie (prior sponsor, Abbott)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mark D McKee, MD AbbVie
PRS Account AbbVie
Verification Date July 2021

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