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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
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Imatinib(Gleevec®) in Selected Patients With Metastatic Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Further study details as provided by Peking University:

Estimated Enrollment: 1
Study Start Date: December 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Imatinib (Gleevec)
    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:

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

Exclusion Criteria:

  1. Melanoma from primary sites other than acral or mucosal melanoma
  2. Received systemic anti-cancer therapy within 1 month before enrollment for metastatic disease
  3. 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
  4. Severe and/or uncontrolled concomitant medical diseases
  5. pregnant or childbreeding women
  6. Known hypersensitivity to imatinib
  7. 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
Beijing, Bejing, China, 10036
Sponsors and Collaborators
Peking University
Novartis
  More Information

No publications provided

Responsible Party: Jun Guo, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT00881049     History of Changes
Other Study ID Numbers: CSTI571BCN19T
Study First Received: April 13, 2009
Last Updated: January 14, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University:
metastatic acral or mucosal melanoma with c-kit mutation or copy number increase

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013