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Report for Clinical Trial NCT01474551

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Single Center Phase II Trial of Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation

The purpose of this study is to find out what effects, good and/or bad, vemurafenib has on the patient and the melanoma. Specifically, the investigators want to know how well vemurafenib shrinks melanoma. The investigators also want to find out how well vemurafenib can improve how well the patient functions.

NCT01474551 Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

1 Interventions

Name: vemurafenib

Description: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.
Type: Drug
Group Labels: 1

vemurafenib


Primary Outcomes

Description: The Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 will be used to determine treatment response. In order to be considered evaluable for response, a patient must have completed at least 1 cycle of therapy. Patients who do not complete a cycle of therapy can be replaced.

Measure: Overall Objective Response

Time: 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 V600E

A Single Center Phase II Trial of Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation. --- V600E ---

Vemurafenib (R05185426) in Poor Performance Status Patients With Unresectable Locally Advanced or Metastatic Melanoma Harboring a V600E/K Mutation The purpose of this study is to find out what effects, good and/or bad, vemurafenib has on the patient and the melanoma. --- V600E ---



HPO Nodes


HPO: