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Report for Clinical Trial NCT01781026

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 2 Study of Neoadjuvant Vemurafenib in Melanoma Patients With Untreated Brain Metastases, Whose Tumors Harbor B-raf Mutations

The purpose of this trial is to study the activity of vemurafenib in untreated melanoma brain metastases harboring B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutations that are not amenable to stereotactic radiosurgery based on size, number of lesions or location, to measure cerebrospinal fluid (CSF) levels of vemurafenib as an indicator of central nervous system penetrance and to measure levels of vemurafenib in normal brain tissue and brain metastases in those in whom surgical management is feasible.

NCT01781026 Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

1 Interventions

Name: Vemurafenib

Description: Single arm trial
Type: Drug
Group Labels: 1

Vemurafenib Administration


Primary Outcomes

Description: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Measure: Activity of Vemurafenib in Untreated Brain Metastases

Time: 1 year

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 V600E

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.. Inclusion Criteria: - Biopsy proven metastatic melanoma with the B-raf V600E or V600K mutations. --- V600E ---

Inclusion Criteria: - Biopsy proven metastatic melanoma with the B-raf V600E or V600K mutations. --- V600E ---


2 V600K

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.. Inclusion Criteria: - Biopsy proven metastatic melanoma with the B-raf V600E or V600K mutations. --- V600E --- --- V600K ---

Inclusion Criteria: - Biopsy proven metastatic melanoma with the B-raf V600E or V600K mutations. --- V600E --- --- V600K ---



HPO Nodes


HPO: