Experimental Drug for Relapsed or Resistant Ovarian Cancer
Name of a Trial
Phase II Study of Birinapant for Advanced Ovarian, Fallopian Tube, and Peritoneal Cancer (NCI-12-C-0191). See a custom summary.
Dr. Christina Annunziata
Dr. Christina Annunziata, NCI Center for Cancer Research
Why This Trial Is Important
Epithelial ovarian cancer is a many common and many lethal form of gynecologic cancer. In 2012, some-more than 22,000 women were approaching to accept a diagnosis of ovarian cancer, and approximately 15,500 were approaching to die from a disease.
Most cases of ovarian cancer, along with a biologically identical fallopian tube and primary peritoneal cancers, primarily respond to diagnosis with debulking medicine and multiple chemotherapy. Some women can't bear surgery, however, and not all respond to chemotherapy. Furthermore, about 80 percent of those who do respond to initial diagnosis will eventually knowledge a relapse.
Although successive chemotherapy might help, a illness roughly always earnings and develops drug resistance. New treatments are desperately indispensable to assistance urge presence for women with these cancers.
An initial drug called birinapant (TL32711) might be a new choice for women with memorable or treatment-resistant ovarian cancer. Birinapant acts as an criminal of a family of proteins called inhibitors of apoptosis (IAPs). These proteins get their name from a purpose they play in controlling apoptosis, that is a form of automatic dungeon genocide that is routinely instituted when cells turn shop-worn or are no longer needed.
IAPs are an essential partial of a mobile signaling pathway that is mostly activated in ovarian and associated cancers. Preclinical studies by researchers during NCI advise that birinapant might interrupt this signaling pathway, that eventually causes ovarian cancer cells to bear apoptosis.
In this proviso II trial, women with metastatic or differently unresectable epithelial ovarian, fallopian tube, or primary peritoneal cancer that has recurred after, or has not responded to, prior therapies will accept birinapant intravenously once a week for a initial 3 weeks of any 4-week cycle. Treatment will continue until illness course or unsuitable toxicity occurs.
“Birinapant has shown really good activity in preclinical in vitro studies and rodent models of ovarian cancer cells,” Dr. Annunziata said. “We’ve conducted in vitro studies in a lab of this drug both with and but TNF [tumor necrosis factor], and it looks like TNF increases a ability of birinapant to kill cancer cells that demonstrate a TNF receptor. Tumor necrosis cause levels have been found to be really high in some women with ovarian cancer, generally in ascites fluid. Birinapant seems to reprogram a TNF response from a dungeon stimulatory pathway to a dungeon genocide pathway.”
Doctors wish to establish a efficiency of birinapant in these cancers, as totalled by altogether response rate or fast illness durability during slightest 6 months. They will also demeanour during altogether survival, toxicity, and a outcome of birinapant on molecular markers, such as TNF, as delegate endpoints.
For More Information
See a lists of eligibility criteria and hearing hit information or call a NCI Clinical Trials Referral Office during 1-888-NCI-1937. The call is fee giveaway and confidential.