NCT00700882

Dasatinib in Treating Patients With Locally Advanced or Metastatic Mucosal Melanoma, Acral Melanoma, or Vulvovaginal Melanoma That Cannot Be Removed By Surgery

A Phase II Trial of Dasatinib in KIT-Positive Patients With Unresectable Locally Advanced or Stage IV Mucosal, Acral and Vulvovaginal Melanomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well dasatinib works in treating patients with locally advanced or metastatic mucosal melanoma or acral melanoma.

Detailed description

OBJECTIVES: Primary * To estimate the objective tumor response rate in patients with KIT-positive, unresectable, locally advanced or metastatic acral or mucosal melanoma treated with dasatinib monotherapy. Secondary * To estimate the response duration in patients treated with this drug. * To estimate the progression-free survival of patients treated with this drug. * To evaluate the safety profile of this drug in these patients. * To evaluate the PDGFR expression and activation of Src family kinases in tumor samples and correlate these parameters with response to treatment. OUTLINE: This is a multicenter study. Patients receive oral dasatinib twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Tissue samples may be collected from some patients for correlative studies. After completion of study therapy, patients are followed up periodically for up to 5 years.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	dasatinib	Patients receive oral dasatinib at 70 mg twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Timeline

• Start date: 2009-07-02
• Primary completion: 2016-05-06
• Completion: 2020-12-28
• First posted: 2008-06-19
• Last updated: 2023-07-03
• Results posted: 2020-02-24

Locations

153 sites across 1 country: United States

Regulatory

• FDA-regulated drug study