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Report for Clinical Trial NCT02257424

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

BRAF, Autophagy and MEK Inhibition in Metastatic Melanoma: A Phase I/II Open-Label Trial of Dabrafenib, Trametinib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma

The primary purpose of this study is to determine the maximum tolerated dose (MTD) and preliminary safety of hydroxychloroquine (HCQ) when administered in conjunction with oral dabrafenib and trametinib (D+T) in patients with advanced BRAF mutant melanoma.

NCT02257424 Advanced BRAF Mutant Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

3 Interventions

Name: Trametinib 2 mg daily

Type: Drug
Group Labels: 1

Phase 1/2

Name: hydroxychloroquine (HCQ)

Description: hydroxychloroquine (HCQ) is 600 mg orally every 12 hours
Type: Drug
Group Labels: 1

Phase 1/2

Name: dabrafenib 150 mg orally twice a day

Type: Drug
Group Labels: 1

Phase 1/2


Primary Outcomes

Description: Phase 1: Maximum tolerated dose (MTD) = a) the dose producing Dose Limiting Toxicity (DLT) in 2/6 patients, or b) the dose level below the dose which produced DLT in ≥ 2/3 patients, or in ≥ 3/6 patients

Measure: Phase 1: To determine the maximum tolerated dose

Time: 5 weeks

Description: Phase 2: Progression free survival (PFS) is defined as the duration of time from start of treatment to time of first progression, death due to any cause or last patient contact alive and progression-free

Measure: Phase 2: To assess the clinical efficacy of HCQ+D+T by 1 year PFS rate.

Time: 1 year

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 4 SNPs

SNPs


1 V600D

- Patients must have histologically confirmed melanoma unresectable Stage III or Stage IV positive for BRAF V600E, V600K, V600R or V600D by a CLIA approved assay. --- V600E --- --- V600K --- --- V600R --- --- V600D ---


2 V600E

- Patients must have histologically confirmed melanoma unresectable Stage III or Stage IV positive for BRAF V600E, V600K, V600R or V600D by a CLIA approved assay. --- V600E ---


3 V600K

- Patients must have histologically confirmed melanoma unresectable Stage III or Stage IV positive for BRAF V600E, V600K, V600R or V600D by a CLIA approved assay. --- V600E --- --- V600K ---


4 V600R

- Patients must have histologically confirmed melanoma unresectable Stage III or Stage IV positive for BRAF V600E, V600K, V600R or V600D by a CLIA approved assay. --- V600E --- --- V600K --- --- V600R ---



HPO Nodes


HPO: