A Randomized, Double-Blind, Placebo-Controlled Phase II Study Of Vtx-2337 In Combination With Pegylated Liposomal Doxorubicin (Pld) In Patients With Recurrent Or Persistent Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Cancer

Conditions

What is the purpose of this trial?

The purpose of this study is to compare the overall survival of patients treated with VTX-2337 + pegylated liposomal doxorubicin (PLD) versus those treated with PLD alone in women with recurrent or persistent, epithelial ovarian, fallopian tube or primary peritoneal cancer.

VTX-2337, a small molecule agonist of Toll-like Receptor 8 (TLR8), activates multiple components of the innate immune system and is being developed as a novel therapeutic agent for use in oncology. Experimental data obtained in an animal model of ovarian cancer supports the combination of VTX-2337 with PLD. In this model, the combination of VTX-2337 and PLD resulted in a significant reduction in tumor growth compared to either agent alone and an increase in the number of T lymphocytes infiltrating the tumor. The combination of PLD and VTX-2337 has been tested in a small number of women with ovarian cancer in a Phase 1b study and appears to be generally well-tolerated.


Participation Guidelines

Age:
18 Years and older
Gender:
Female

Click here for detailed information about who can participate in this trial.


Sponsor:
Gynecologic Oncology Group
Dates:
09/12/2013
Last Updated:
Study HIC#:
1307012429