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NCT04169763 · ClinicalTrials.gov registry record · Phase 1
Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery
A Phase 1 study of Stage III Vulvar Cancer AJCC v8 and Stage II Vulvar Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT04169763 is a Phase 1 study of Stage III Vulvar Cancer AJCC v8 and Stage II Vulvar Cancer AJCC v8 that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 25 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04169763, a Phase 1 study of Stage III Vulvar Cancer AJCC v8 and Stage II Vulvar Cancer AJCC v8, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects and best dose of nelfinavir when given together with cisplatin and external beam radiation therapy in treating patients with vulvar cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery. Nelfinavir is an antiviral drug normally used to treat human immunodeficiency virus (HIV). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving nelfinavir, cisplatin, and external beam radiation therapy may work better than giving only cisplatin and external beam radiation therapy in treating patients with vulvar cancer.
Conditions Studied
Interventions
- DRUG Cisplatin
- RADIATION External Beam Radiation Therapy
- DRUG Nelfinavir
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-08-07 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04169763
The ClinicalTrials.gov registry entry for NCT04169763 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Stage III Vulvar Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Cisplatin is the first listed.
NCT04169763 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04169763 about?
NCT04169763 is a clinical study titled "Nelfinavir, Cisplatin, and External Beam Radiation Therapy for the Treatment of Locally Advanced Vulvar Cancer That Cannot Be Removed by Surgery". This phase I trial studies the side effects and best dose of nelfinavir when given together with cisplatin and external beam radiation therapy in treating patients with vulvar cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery. Nelfinavir is an...
What is the current status of trial NCT04169763?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2020-08-07. Estimated completion is 2026-12-31.
What conditions does trial NCT04169763 study?
This clinical trial studies the following conditions: Stage III Vulvar Cancer AJCC v8, Stage II Vulvar Cancer AJCC v8, Stage IIIA Vulvar Cancer AJCC v8, Stage IIIB Vulvar Cancer AJCC v8, Stage IIIC Vulvar Cancer AJCC v8.
What interventions are being tested in trial NCT04169763?
The interventions under investigation include: Cisplatin (DRUG), External Beam Radiation Therapy (RADIATION), Nelfinavir (DRUG).
Who is sponsoring clinical trial NCT04169763?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04169763 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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