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

This study has been completed.

Sponsor:

Collaborator:

Novartis

Information provided by:

Peking University

ClinicalTrials.gov Identifier:

NCT00881049

First received: April 13, 2009

Last updated: January 14, 2011

Last verified: January 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	April 13, 2009
Last Updated Date	January 14, 2011
Start Date ^ICMJE	December 2008
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00881049 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Trial of Imatinib (Gleevec®) in Selected Patients With Metastatic Melanoma
Official Title ^ICMJE	Phase II Trial of Imatinib(Gleevec®) in Selected Patients With Metastatic Melanoma
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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Metastatic Melanoma
Intervention ^ICMJE	Drug: Imatinib (Gleevec) Imatinib will be given for enrolled patients to investigate efficacy and safety
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	1
Completion Date	January 2011
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 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
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT00881049
Other Study ID Numbers ^ICMJE	CSTI571BCN19T
Has Data Monitoring Committee	No
Responsible Party	Jun Guo, Beijing Cancer Hospital
Study Sponsor ^ICMJE	Peking University
Collaborators ^ICMJE	Novartis
Investigators ^ICMJE	Not Provided
Information Provided By	Peking University
Verification Date	January 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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