Study of Safety & Biological Activity of IP IMNN-001 (also Known As GEN-1) with Neoadjuvant Chemo in Ovarian Cancer
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Imunon
- Study ID
- NCT02480374
- Phase
- PHASE1
- Status
- Completed
Conditions
- Epithelial Ovarian Cancer
- Fallopian Tube Cancer
- Primary Peritoneal Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- IMNN-001 — BIOLOGICAL
Study Details
This dose escalation study will determine a maximum tolerated dose and/or optimal biological dose of GEN-1 for carboplatin/paclitaxel combination in newly diagnosed ovarian cancer.
Key Dates
- Start date
- Sep 30, 2015
- Status verified
- Oct 2024
- Primary completion
- May 31, 2017
- Completion
- May 31, 2017
Study Design
- Enrollment
- 18 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Single ArmCarboplatin + Paclitaxel + IMNN-001
Primary Outcome Measure
DLT [ Time Frame: 4 weeks ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama Birmingham Cancer Center | Birmingham | Alabama | 35233 | - |
| Washington Univ. in St. Louis/Barnes Jewish Hospital | St Louis | Missouri | 63110 | - |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | - |
| Medical College of Wisconsin/Froedtert Hospital | Milwaukee | Wisconsin | 53226 | - |
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