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NCT03393884 · ClinicalTrials.gov registry record · Phase 1
Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2)
A Phase 1 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer, sponsored by Imunon.
- Active
- Registry status
- Phase 1
- Development phase
- 130
- Enrollment target
- 20
- Study locations
NCT03393884: Active Phase 1 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer, sponsored by Imunon.
NCT03393884 is a Phase 1 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer that is active but no longer recruiting, run by Imunon. The registered enrollment target is 130 participants, below the 254-participant average among 85 other Fallopian Tube Cancer trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03393884, a Phase 1 study of Fallopian Tube Cancer and Epithelial Ovarian Cancer, is active but no longer recruiting, sponsored by Imunon.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 130 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal IMNN-001 plus NACT compared to NACT alone.
Primary Outcome
The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus IMNN-001 versus standard NACT.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Paclitaxel
- BIOLOGICAL IMNN-001
Study Locations (20)
New York
- Monter Cancer Center - Lake Success
- NYU Langone, Long Island - Mineola
- NYU Langone - New York
Alabama
- University of Alabama Birmingham - Birmingham
- Mitchell Cancer Institute (University of South Alabama) - Mobile
California
- Gynecologic Oncology Associates (Hoag Hospital) - Newport Beach
- Innovative Clinical Research - Whittier
Florida
- Advent Health - Orlando
- Women's Care Florida - St. Petersburg
New Jersey
- MD Anderson at Cooper - Camden
- Hackensack University Medical Center - Hackensack
Tennessee
- Chattanooga Women's Health - Chattanooga
- The West Clinic - Germantown
Massachusetts
- Massachusetts General Hospital - Boston
Missouri
- Washington University School of Medicine in St. Louis - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2018-09-05 |
| Est. Completion | 2026-03-30 |
| Phase | Phase 1 |
What the registry record for NCT03393884 still lists
NCT03393884 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 254-participant average among 85 other Fallopian Tube Cancer trials with a reported enrollment target (49% lower).
The record links to 3 conditions, with Fallopian Tube Cancer appearing as the primary indexed condition, and to 3 interventions - of which Carboplatin is the first listed.
NCT03393884 names 20 study sites across 13 states, led by New York, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT03393884 about?
NCT03393884 is a clinical study titled "Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2)". This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal IMNN-001 plus NACT compared to NACT alone.
What is the current status of trial NCT03393884?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 130 participants. The study started on 2018-09-05. Estimated completion is 2026-03-30.
What conditions does trial NCT03393884 study?
This clinical trial studies the following conditions: Fallopian Tube Cancer, Epithelial Ovarian Cancer, Primary Peritoneal Cancer.
What interventions are being tested in trial NCT03393884?
The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), IMNN-001 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03393884?
This trial is sponsored by Imunon, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03393884 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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.
Where NCT03393884's enrollment target sits among peer trials
130 28th of 85 higher than 58 of 85 other Fallopian Tube Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fallopian Tube Cancer 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.
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