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Report for Clinical Trial NCT02143050

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase I/II Trial of Dabrafenib, Trametinib and Metformin Administered to Unresectable Stage IIIC and Stage IV BRAF V600E + Melanoma Patients

The main purpose is to evaluate the clinical response, safety and survival of the FDA approved drugs Dabrafenib, Trametinib in combination with Metformin. Investigators hypothesize that the combination of an FDA approved non toxic dose of oral Metformin with the B-Raf inhibitor, Dabrafenib and the MEK inhibitor, Trametinib will yield little toxicity and improve clinical outcomes in terms of objective response rates and survival in metastatic melanoma patients.

NCT02143050 Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

3 Interventions

Name: Dabrafenib

Type: Drug
Group Labels: 1

Dabrafenib, Trametinib and Metformin

Name: Trametinib

Type: Drug
Group Labels: 1

Dabrafenib, Trametinib and Metformin

Name: Metformin

Type: Drug
Group Labels: 1

Dabrafenib, Trametinib and Metformin


Primary Outcomes

Description: During phase I, six patients will be enrolled and monitored for toxicities. If drug related deaths occur or more than two drug related CTCAE grade 4 toxicities occur the trial will be suspended. Phase II will estimate the efficacy of the drugs, enrolling 20 patients during stage 1 with an upper limit of 39 for the 2nd stage.

Measure: Observation of two CTCAE drug related grade 4 toxicities in six patients.

Time: Duration of phase I portion, approxiately 6 months

Description: Phase II will study the efficacy of the drugs enrolling 20 patients during stage I with an upper limit of 39 for the 2nd stage.

Measure: Clinical Response Rate

Time: 6 years

Secondary Outcomes

Description: Patients will be contacted every 3 months following treatment administration for up to three years to obtain survival data.

Measure: To estimate the overall survival rates.

Time: Approximately 3 years

Description: To identify demographic, disease and treatment related effects on overall survival.

Measure: To explore the effect of other covariates on overall survival

Time: 3 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

A Phase I/II Trial of Dabrafenib, Trametinib and Metformin Administered to Unresectable Stage IIIC and Stage IV BRAF V600E + Melanoma Patients. --- V600E ---



HPO Nodes


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