A Clinical Study Conducted in Multiple Centers Evaluating Escalating Doses of Veliparib in Combination With Capecitabine and Radiation in Patients With Locally Advanced Rectal Cancer

Study Identifier
M12-950
CT.gov Identifier
NCT01589419
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
  • Colorectal Cancer
    • Study Drug
  • veliparib
  • capecitabine
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Subject must be ≥ 18 years of age * All subjects must have newly diagnosed, histologically proven adenocarcinoma of the rectum * All subjects must have an abdominal/pelvis computed tomography (CT ) scan or magnetic resonance imaging (MRI) confirming no evidence of distant metastases * Distal border of tumor \< 12 cm from anal verge * Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 to 2 * No prior treatment for LARC however prior treatments for other cancers are acceptable as long as they are considered curative
    Exclusion Criteria:
    * Subject is an unsuitable candidate for TME surgery * Subject has received anticancer therapy * Subject has received prior radiation therapy * Subject has had major surgery within 28 days prior to the first dose of study drug * History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption

    Protocol Summary

    An open-label, Phase 1b, dose escalation study evaluating the safety and tolerability of the PARP inhibitor Veliparib in combination with capecitabine and radiation in subjects with locally advanced rectal cancer (LARC).

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 99095
    Scottsdale, Arizona, United States, 85258
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 68044
    Chicago, Illinois, United States, 60611
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 112395
    Goshen, Indiana, United States, 46526
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 68045
    Durham, North Carolina, United States, 27710
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 68043
    Madison, Wisconsin, United States, 53792
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 67882
    East Melbourne, Australia, 3002
    Status
    Not applicable