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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: Recruiting Phase 1 study of Melanoma, sponsored by University of Louisville.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
In the phase I portion, six patients will be enrolled and observed for CTCAE grade 4 or higher events. If three or more grade 4 or higher adverse events are observed among the six patients, the study will be halted.
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 |
What NCT01638676 shows while recruiting
NCT01638676 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Melanoma
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 NCT01638676's enrollment target sits among peer trials
55 157th of 266 higher than 110 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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