Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Vemurafenib and Metformin in BRAF V600E+ Melanoma
NCT01638676Phase 2
Key facts
- Status
- Recruiting
- Start
- Jul 2012
- Primary completion
- Jun 2025
- Countries
- 1
- Sponsor
- University of Louisville
- Modality
- Small Molecules
- Conditions
- melanoma
01
Overview
Phase 2, open-label, single-arm trial of vemurafenib and liquid metformin (Aspargo Labs) in melanoma, sponsored by University of Louisville. Primary endpoint: Observation of CTCAE grade 4 or higher adverse events at 6 months. Started Jul 2012; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Vemurafenib and Metformin
Vemurafenib (960 mg PO daily) + Metformin (500 mg PO BID x 2 weeks, then 850 mg PO BID)
03
Who it enrols
Adult patients with unresectable Stage IIIC or Stage IV BRAF V600E-mutated melanoma, ECOG 0-2, adequate organ function, and no prior treatment with Vemurafenib.
04
Endpoints
Primary
Observation of CTCAE grade 4 or higher adverse events
Secondary
Overall Survival
Number of adverse events
Type of adverse events
Objective Response Rate
Beyond the preview
Go deeper on NCT01638676.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT01638676.