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NCT01666444 · ClinicalTrials.gov registry record · Phase 2
VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
A Phase 2 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer, sponsored by Celgene.
- Completed
- Registry status
- Phase 2
- Development phase
- 297
- Enrollment target
- 20
- Study locations
NCT01666444: Completed Phase 2 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer, sponsored by Celgene.
NCT01666444 is a Phase 2 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer that has completed, run by Celgene. The registered enrollment target is 297 participants, above the 252-participant average among 85 other Fallopian Tube Cancer trials with a reported enrollment target (18% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01666444, a Phase 2 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 297 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Comparison of duration of survival between the 2 treatment groups
Conditions Studied
Interventions
- DRUG Placebo
- DRUG pegylated liposomal doxorubicin (PLD)
- DRUG VTX-2337
Study Locations (20)
California
- Providence Saint Joseph Medical Center - Burbank
- Kaiser Permanente Medical Center - Hayward
- Long Beach Memorial Medical Center - Long Beach
- Kaiser Permanente Medical Center - Oakland
- Kaiser Permanente Medical Center - Roseville
- Sutter Cancer Center - Sacramento
- Kaiser Permanente Medical Center - Sacramento
- Kaiser Permanente Medical Center - San Francisco
- Kaiser Permanente Medical Center - San Jose
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente Medical Center - South San Francisco
- Stanford University School of Medicine - Stanford
- Kaiser Permanente Medical Center - Vallejo
- Kaiser Permanente Medical Center - Walnut Creek
Connecticut
- Hartford Hospital - Hartford
- St. Francis Hospital and Medical Center - Hartford
- The Hospital of Central Connecticut - New Britain
Arizona
- St. Joseph's Hospital and Medical Center - Phoenix
Arkansas
- Winthrop P. Rockefeller Cancer Institute - University of Arkansas - Little Rock
Colorado
- University of Colorado Cancer Center - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 297 participants |
| Start Date | 2012-10-31 |
| Est. Completion | 2016-07-31 |
| Phase | Phase 2 |
What the finished NCT01666444 record still lists
NCT01666444 is an interventional study that assigns participants to a tested intervention. The registered 297 participants enrollment target is mid-sized for trials with a published cap, above the 252-participant average among 85 other Fallopian Tube Cancer trials with a reported enrollment target (18% higher).
The record links to 3 conditions, with Fallopian Tube Cancer appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01666444 names 20 study sites across 5 states, led by California, Connecticut, Arizona.
Frequently Asked Questions
What is clinical trial NCT01666444 about?
NCT01666444 is a clinical study titled "VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer". 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 molecu...
What is the current status of trial NCT01666444?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 297 participants. The study started on 2012-10-31. Estimated completion is 2016-07-31.
What conditions does trial NCT01666444 study?
This clinical trial studies the following conditions: Fallopian Tube Cancer, Epithelial Ovarian Cancer, Primary Peritoneal Cancer.
What interventions are being tested in trial NCT01666444?
The interventions under investigation include: Placebo (DRUG), pegylated liposomal doxorubicin (PLD) (DRUG), VTX-2337 (DRUG).
Who is sponsoring clinical trial NCT01666444?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01666444 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01666444's enrollment target sits among peer trials
297 18th of 85 higher than 68 of 85 other Fallopian Tube Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fallopian Tube Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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