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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: Completed Phase 1 study, sponsored by Gynecologic Oncology Group.
NCT01489371 is a Phase 1 study that has completed, run by Gynecologic Oncology Group. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-07-09 |
| Est. Completion | 2018-01-27 |
| Phase | Phase 1 |
What the finished NCT01489371 record still lists
NCT01489371 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01489371 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01489371's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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