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NCT01638676 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
A Phase 1 study of Melanoma, sponsored by University of Louisville.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT01638676 is a Phase 1 study of Melanoma that is actively recruiting participants, run by University of Louisville. The registered enrollment target is 55 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01638676, a Phase 1 study of Melanoma, is actively recruiting participants, sponsored by University of Louisville.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose of this study is to evaluate the safety of Vemurafenib in combination with Metformin in melanoma patients. The phase II part of the study will also evaluate the clinical activity of the combined regiment. Based on pre-clinical studies and a phase I trial, the investigators hypothesize that the combination of an FDA-approved non-toxic dose of oral Metformin with Vemurafenib will yield little toxicity and improve clinical outcomes in terms of objective response rates and survival in metastatic melanoma patients.
Conditions Studied
Interventions
- DRUG Metformin
- DRUG Vemurafenib
Study Locations (1)
Kentucky
- James Graham Brown Cancer Center-University of Louisville - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2012-07 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01638676
The ClinicalTrials.gov registry entry for NCT01638676 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (92% lower). The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Metformin is the first listed.
NCT01638676 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.
Frequently Asked Questions
What is clinical trial NCT01638676 about?
NCT01638676 is a clinical study titled "A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients". The main purpose of this study is to evaluate the safety of Vemurafenib in combination with Metformin in melanoma patients. The phase II part of the study will also evaluate the clinical activity of the combined regiment. Based on pre-clinical studies and a phase I trial, the investigators hypothesi...
What is the current status of trial NCT01638676?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2012-07. Estimated completion is 2027-06.
What conditions does trial NCT01638676 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT01638676?
The interventions under investigation include: Metformin (DRUG), Vemurafenib (DRUG).
Who is sponsoring clinical trial NCT01638676?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01638676 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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