G0821 A Randomized Phase II/III Study to Assess the Efficacy of Trametinib (GSK1120212) in Patients with Recurrent or Progressive Low-grade Serous Ovarian Cancer or Primary Peritoneal Cancer
This research is being done to to compare the effects of trametinib with one of the standard treatments available that your doctor will choose for you (either letrozole, tamoxifen, paclitaxel, Pegylated Liposomal Doxorubicin (PLD), or topotecan) to treat your low-grade serous ovarian or peritoneal cancer to find out which works is better to control your cancer.
- Recurrent or progressive low-grade serous ovarian or primary peritoneal cancer - Measurable disease - Disease that can be biopsied - Received a minimum of 1 prior platinum chemotherapy regimen - No prior MEK, KRAS or BRAF inhibitors - Recovered prior prior therapy, lab values and performance status within normal limits - Can't have recieved all of the physician choice options of treatment
Randomized to receive Trametinib orally daily for 28-day cycles or to receive your physician's choice of commercially available agents (Taxol, Topotecan, Doxil, Letrozole or Tamoxifen). All treatments are outpatient. If you are randomized to the phyician's choice of treatment arm and it does not work, you will have the option of crossing over to receive the Trametinib.
09/22/2014 04:03 AM