Trial of Imatinib (Gleevec®) in Selected Patients With Metastatic Melanoma

NCT00881049 | Completed Phase 2

• 1 other identifier: CSTI571BCN19T
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-armed, open-label, single-center phase II trial of signal transduction inhibitor number 571 (STI-571) systemic therapy in selective patients with metastatic melanoma, and aims to study the efficacy and safety. The primary endpoint is progression-free survival (PFS) and the second endpoints are overall response rate (ORR), overall survival (OS), 1-year OS and safety.

Conditions

Metastatic Melanoma

Keywords

metastatic acral or mucosal melanoma with c-kit mutation or copy number increase

Interventions

Imatinib (Gleevec) DRUG

Imatinib will be given for enrolled patients to investigate efficacy and safety

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed melanoma with metastases and has no received any systemic treatment within 1 month
• Evidence of mutations and/or copy number increases of KIT with laboratory examination documented from either primary or metastatic tumor site
• ECOG performance status 0, 1, or 2
• Estimated life expectancy of 6 months or greater
• Age 18 years or older, male of female
• At least one measurable site of disease
• Adequate organ function
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

You may not qualify if:

• Melanoma from primary sites other than acral or mucosal melanoma
• Received systemic anti-cancer therapy within 1 month before enrollment for metastatic disease
• Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer
• Severe and/or uncontrolled concomitant medical diseases
• pregnant or childbreeding women
• Known hypersensitivity to imatinib
• Current treatment on another clinical trial

Sponsors & Collaborators

• Peking University: lead
• Novartis: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Bejing, 10036, China

Location

MeSH Terms

Conditions

Melanoma

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 14, 2009
• Study Start: December 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 17, 2011

Record last verified: 2011-01

Locations

CN (1)