Trial of Imatinib (Gleevec®) in Selected Patients With Metastatic Melanoma - Full Text View

Sponsors and Collaborators:	Peking University Novartis
Information provided by:	Peking University
ClinicalTrials.gov Identifier:	NCT00881049

Purpose

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.

Condition	Intervention	Phase
Metastatic Melanoma	Drug: Imatinib (Gleevec)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of Imatinib(Gleevec®) in Selected Patients With Metastatic Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by Peking University:

Estimated Enrollment:	1
Study Start Date:	December 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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

Detailed Description:

Only patients who meet the inclusion and exclusion criteria will be enrolled. The estimated recruitment duration is 1 year. Imatinib will be given in the dose of 400 mg orally each day unless disease progression or intolerance. The follow-up is 12 months. Forty-eight subjects will be recruited for this study. This sample size is justified by the number of patients required to establish an improvement in PFS with statistical significance compared to historical control.

The standardized RECIST (Response Evaluation Criteria in Solid Tumors) method of unidimensional tumor assessment will be employed to evaluate tumor lesion size per 2 months in the determination of response rate and progression free survival. Repeated radiographic assessment at 4 week intervals is consistent with general oncological practice associated with computerized tomography (CT) or magnetic resonance imaging (MRI) scan testing. All efficacy endpoints will be evaluated by the investigator.

Safety will be characterized in terms of the incidence, timing, severity, and relatedness of adverse events and laboratory abnormalities. Severity will be graded according to the NCI CTCAE Version 3.0.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed acral/lentiginous or mucosal 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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881049

Locations

China, Bejing
Beijing Cancer Hospital	Recruiting
Beijing, Bejing, China, 10036
Contact: Jun Guo, M.D. 010-88121122 Guoj307@126.com
Principal Investigator: Jun Guo, M.D.

Sponsors and Collaborators

Peking University

Novartis

More Information

No publications provided

Responsible Party:	Beijing Cancer Hospital ( Jun Guo )
Study ID Numbers:	CSTI571BCN19T
Study First Received:	April 13, 2009
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00881049 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by Peking University:

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

Study placed in the following topic categories:

Imatinib
Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Protein Kinase Inhibitors
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Melanoma

Neuroendocrine Tumors
Imatinib
Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 04, 2009