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NCT01489371 · ClinicalTrials.gov registry record · Phase 1

EGEN-001 and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

A Phase 1 study, sponsored by Gynecologic Oncology Group.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT01489371 is a Phase 1 study that has completed, run by Gynecologic Oncology Group. The registered enrollment target is 16 participants.

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The verdict

NCT01489371, a Phase 1 study, has completed, sponsored by Gynecologic Oncology Group.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and the best dose of giving EGEN-001 together with pegylated liposomal doxorubicin hydrochloride in treating patients with ovarian epithelial, fallopian tube, or primary peritoneal cancer that has returned after a period of improvement or has not responded to treatment. Biological therapies, such as EGEN-001, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving EGEN-001 together with pegylated liposomal doxorubicin hydrochloride may kill more tumor cells.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Pegylated Liposomal Doxorubicin Hydrochloride
  • BIOLOGICAL PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2012-07-09
Est. Completion 2018-01-27
Phase Phase 1

Sponsor

Gynecologic Oncology Group

154 total trials

What the Registry Record Tells You About NCT01489371

The ClinicalTrials.gov registry entry for NCT01489371 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gynecologic Oncology Group, which has 154 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT01489371 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01489371 about?

NCT01489371 is a clinical study titled "EGEN-001 and Pegylated Liposomal Doxorubicin Hydrochloride in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer". This phase I trial studies the side effects and the best dose of giving EGEN-001 together with pegylated liposomal doxorubicin hydrochloride in treating patients with ovarian epithelial, fallopian tube, or primary peritoneal cancer that has returned after a period of improvement or has not responded...

What is the current status of trial NCT01489371?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2012-07-09. Estimated completion is 2018-01-27.

What interventions are being tested in trial NCT01489371?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Pegylated Liposomal Doxorubicin Hydrochloride (DRUG), PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1 (BIOLOGICAL).

Who is sponsoring clinical trial NCT01489371?

This trial is sponsored by Gynecologic Oncology Group, which has 154 total clinical trials registered on ClinicalTrials.gov.

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

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.