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COMPLETED Phase 2

VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

NCT01666444 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 297 participants
Start Date 2012-10-31
Est. Completion 2016-07-31
Phase Phase 2

Sponsor

Celgene

73 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 297 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01666444 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Connecticut, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01666444?

The interventions under investigation include: Placebo (DRUG), pegylated liposomal doxorubicin (PLD) (DRUG), VTX-2337 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01666444?

This trial is sponsored by Celgene, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial