Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01666444
The ClinicalTrials.gov registry entry for NCT01666444 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 297 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 252-participant average among 85 other Fallopian Tube Cancer trials with a reported enrollment target (18% higher). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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
Similar trials for Fallopian Tube Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer
RECRUITING · Phase 2
-
Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers
RECRUITING · Phase 2
-
An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib
RECRUITING · Phase 2
-
A Study to Assess Change in Disease Activity and Adverse Events in Adult Participants With Gynecologic Cancers Receiving Intravenous Infusion of IMGN151 as Monotherapy or in Combination With Other Therapies
RECRUITING · Phase 2
-
A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
RECRUITING · Phase 2
-
CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.
RECRUITING · Phase 2
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.