Open-Label Extension and Safety Study of Talazoparib

A Single-Arm, Open-Label, Multicenter, Extended Treatment, Safety Study in Patients Treated With Talazoparib

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Larney, Patricia; Morales, Leticia; Pelley, Jennifer; Rompola, Melissa; Johnson, Teal; Walton, Sherri

    Trial Phone: 321.841.2042 ; 321.841.6696 ; 321.841.4348 ; 321.841.7022 ; 321.843.2546 ; 321.841.1907

  • IRB No: WIRB 1167772

    Protocol Abbrev: TRIO MDV3800-13

    Principal Investigator: Rebecca L. Moroose, MD

    Sub Investigators: Baidas, Said MD; Cuesta, Ana MD; Hajdenberg, Julio MD; Johnson, Tirrell MD; Landau, Daniel MD; Neely, Lindsey ARNP; Rostorfer, Regan MD; Shah, Nikita MD; Tseng, Jennifer MD

    Phase: Drug: Phase II

    Age Group: Adult

    Treatment: Medication

    Applicable Disease Sites: Breast, Melanoma, GI, Lung, GYN, Head and Neck, GU, Hem

    Therapies Involved: Talazoparib ID: NCT02921919

  • Objective

    3. Investigate predictors of program retention.

  • Key Eligibility

    Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
    Female patients of childbearing potential must have a negative pregnancy test before the first dose of talazoparib and must agree to use a highly effective birth control method from the time of the first dose of talazoparib through 45 days after the last dose.
    Male patients must use a condom when having sex with a pregnant woman or with a woman of childbearing potential from the time of the first dose of talazoparib through 105 days after the last dose. Contraception should be considered for a nonpregnant female partner of childbearing potential.
    Female patients may not be breastfeeding at the first dose of talazoparib and must not breastfeed during study participation through 45 days after the last dose of talazoparib