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

Study Identifier
M10-758
CT.gov Identifier
NCT01063816
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Solid Tumors (General)
    • Study Drug
  • veliparib (ABT-888)
  • carboplatin
  • gemcitabine
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    No locations found.