CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 297 enrolled
Drug / intervention
pegylated liposomal doxorubicin (PLD) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01666444
NCT01666444Phase 2Completed

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

Celgene·interventional·Posted Aug 16, 2012·Updated Sep 26, 2019

In Brief

A Phase 2 clinical trial evaluating pegylated liposomal doxorubicin (PLD), VTX-2337, and 1 other intervention for Epithelial Ovarian Cancer and 2 related conditions. Completed, enrolled 297 participants across 136 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 16, 2012
Enrollment StartOct 31, 2012
Primary CompletionJul 31, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.9 years ago

Interventions

pegylated liposomal doxorubicin (PLD)drug

VTX-2337drug

TLR8 Agonist

Placebodrug