A Randomized Phase II/III Study To Assess The Efficacy Of Trametinib (Gsk 1120212) In Patients With Recurrent Or Progressive Low-Grade Serous Ovarian Cancer Or Peritoneal Cancer.
Posted Date: Jun 18, 2014
- Investigator: Eric Eisenhauer
- Type of Study: Drug
The purpose of this study is 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. In this study, you will get either the trametinib or one of the standard treatments available. You will not get both at the same time. Trametinib is a drug that blocks a very important signal that controls the growth of cancer cells. It is thought that this signal is important in a variety of cancers, including low-grade serous ovarian and peritoneal cancers. Trametinib is experimental and has not yet been studied in patients with low-grade serous ovarian or peritoneal cancer. In addition to the treatment part of this study, the researchers plan to test samples of your tumor and some of your blood. The purpose of this research is to determine whether the presence of certain proteins and genes predict if this drug will be an effective treatment for ovarian or peritoneal cancer. The researchers will also use samples of your blood to determine how much of the study drug (trametinib) is present in your blood.
You Are Being Asked To Take Part In This Study Because You Have Low Grade Ovarian Or Peritoneal Cancer Which Has Spread Outside Of Your Ovaries.
Gynecologic Oncology, Low Grade, Ovarian Cancer, Recurrent, Null
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