drugset / Trial / NCT01092728

Treatment With Dasatinib in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma

NCT01092728

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to compare how the drug Sprycel (dasatinib) can help to control the tumor in Patients With Acral Lentiginous, Mucosal, or Chronic Sun-damaged Melanoma. The safety of this drug will also be studied. Objectives: Primary Objectives: 1\. To compare the biological response of tumors With and Without Resectable Tumors from patients with acral, or mucosal melanomas after treatment with dasatinib. Secondary Objectives: 1. To assess the safety and tolerability of dasatinib in this patient population Completely Resectable Acral, Chronic Sun-damaged (CSD), and Mucosal Melanoma: 2. To assess the median time to recurrence and overall survival of patients with completely resectable acral, CSD, and mucosal melanoma treated with dasatinib 3. To assess whether FDG-avidity and KIT phosphorylation responses after treatment with dasatinib predicts prolonged time to recurrence and/or overall survival in patients with completely resectable acral, CSD, and mucosal melanomas Not Completely Resectable Acral, CSD, and Mucosal Melanoma: 4. To assess the response rate, progression free survival, and overall survival of patients with acral, CSD, and mucosal melanoma treated with dasatinib 5. To assess whether FDG-avidity and KIT phosphorylation responses after treatment with dasatinib predicts response rate, progression free survival, and/or overall survival in patients with acral, CSD, and mucosal melanomas

Timeline

Start
2011-03
Primary completion
2014-08
Completion
2014-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator dasatinib anhydrous Small molecule 100 mg Oral

Indications