CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01118052
NCT01118052Phase 2Completed

A Phase II Evaluation of Intraperitoneal EGEN-001 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Gynecologic Oncology Group·interventional·Posted May 6, 2010·Updated Jan 11, 2018

In Brief

A Phase 2 clinical trial evaluating Laboratory Biomarker Analysis and PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1 for Fallopian Tube Carcinoma and 2 related conditions. Completed, enrolled 22 participants across 11 sites.

Detailed Summary

This phase II trial studies the side effects and how well EGEN-001 works in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that is persistent or has come back. Biological therapies, such as EGEN-001, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 6, 2010
Enrollment StartNov 1, 2010
Primary CompletionJul 16, 2016
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 16.2 years ago

Interventions

Laboratory Biomarker Analysisother

Correlative studies

PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1biological

Given intraperitoneally