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

Primary Purpose

Metastatic Melanoma

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Imatinib (Gleevec)
Sponsored by
Peking University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring metastatic acral or mucosal melanoma with c-kit mutation or copy number increase

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Cancer Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 13, 2009
Last Updated
January 14, 2011
Sponsor
Peking University
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00881049
Brief Title
Trial of Imatinib (Gleevec®) in Selected Patients With Metastatic Melanoma
Official Title
Phase II Trial of Imatinib(Gleevec®) in Selected Patients With Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Peking University
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Melanoma
Keywords
metastatic acral or mucosal melanoma with c-kit mutation or copy number increase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Imatinib (Gleevec)
Intervention Description
Imatinib will be given for enrolled patients to investigate efficacy and safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Bejing
ZIP/Postal Code
10036
Country
China

12. IPD Sharing Statement

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

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