Cediranib Maleate and Olaparib or Standard Chemotherapy in Treati

To assess the efficacy and identify (in)active arm(s) of the combination of cediranib (cediranib maleate) and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by progression-free survival (PFS) in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase II) II. To assess the efficacy of the combination of cediranib and olaparib, and active monotherapy experimental arm(s) from Randomized Phase II, as measured by overall survival (OS) and PFS, as compared to physician's choice standard of care chemotherapy in women with recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase III) To assess the efficacy of the combination of cediranib and olaparib, cediranib alone, olaparib alone, and physician's choice standard of care chemotherapy, as measured by objective response rate (ORR: partial or complete response) by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase II) II. To assess safety endpoints, as measured by frequency and severity of adverse events by Common Terminology Criteria for Adverse Events (CTCAE) version (v).4.0. (Phase II and Phase III) III. To assess the efficacy of the combination of cediranib and olaparib, and active monotherapy experimental arm(s) from Randomized Phase II, as measured by ORR, as compared to physician's choice standard of care chemotherapy in the setting of recurrent platinum-resistant or-refractory ovarian, primary peritoneal or fallopian tube cancer. (Phase III)

July 03, 2017

  • Clinical Trial Information

    Trial Contact: Quintiliani, Jennifer

    Trial Phone: 321.843.2026

  • Age Group: Adult

    Phase: Drug: Phase II

    Principal Investigator: Veronica L Schimp, DO

    Sub Investigators: Ganesh K. Akula, MD;

    IRB No:

    Secondary Protocol No: NRG GY005

    Applicable Disease Sites: Ovarian, Fallopian Tube or Primary Peritoneal Cancer