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

NCT01092728 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-09-05

Study results available
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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

Conditions

Interventions

DRUG

Dasatinib

100 mg daily.

PROCEDURE

Surgical Resection

Complete surgical resection of tumor(s).

Sponsors & Collaborators

Principal Investigators

  • Kevin B. Kim, MD, BA · UT MD Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01092728 on ClinicalTrials.gov