GDC-0449 maintenance in ovarian cancer in 2nd/3rd complete remission

• Research type

  Research Study

• Full title

  A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL EVALUATING THE EFFICACY AND SAFETY OF GDC-0449 AS MAINTENANCE THERAPY IN PATIENTS WITH OVARIAN CANCER IN A SECOND OR THIRD COMPLETE REMISSION.

• IRAS ID

  8384

• Contact name

  Stanley Kaye

• Sponsor organisation

  Genentech Inc

• Eudract number

  2008-003789-24

• ISRCTN Number

  N/A

• Research summary

  Ovarian cancer is a disease with ongoing, significant unmet medical need. Most patients with ovarian cancer are diagnosed with advanced (Stage III or Stage IV) disease and are treated with surgery followed by either intravenous (an injection into the vein) or intra-peritoneal (an injection into the peritoneum or Ó?body cavity?) chemotherapy (use of drugs to treat cancer). Although many patients respond to initial therapy, the majority will experience disease recurrence and will require additional chemotherapy. For patients with recurrent disease, further chemotherapy (either platinum-based or non-platinum-based) is indicated. However, maintenance chemotherapy is not the standard of care for patients in second complete remission, and a medical need exists for new therapies that can prolong progression-free survival (PFS) in this setting, which is approximately 10 months. In this study, we aim to estimate the clinical benefit of maintenance therapy with GDC-0449 (Hedgehog Pathway Inhibitor) in second or third complete remission, as measured by PFS (primary outcome measure). Participants will be randomised in a 1:1 ratio to either GDC-0449 or placebo. Randomisation will be stratified based on whether their cancer is in a second or third complete remission. Treatment will continue until evidence of radiographic progression (the cancer starts growing again), until the participant experiences intolerable toxicities most probably due to GDC-0449, or until the participant withdraws from the study. Participants who discontinue study treatment will be followed for survival approximately every 3 months until death, loss to follow-up, or study termination by Genentech.This study will be sponsored by Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080-4990 U.S.A. A total of 100 patients will be enrolled at up to 50 sites in approximately 10 countries.

• REC name

  London - South East Research Ethics Committee

• REC reference

  08/H1102/105

• Date of REC Opinion

  24 Dec 2008

• REC opinion

  Further Information Favourable Opinion