Status:
WITHDRAWN
Role of Glivec in Patients With Tumor Cells Positive for C-kit or PDGFR; a Multi Center Study.
Lead Sponsor:
Hadassah Medical Organization
Collaborating Sponsors:
Novartis
Conditions:
Metastatic Solid Tumors.
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II, multi-center (Israeli), open label, non-randomized trial for every patient with the specified tumors expressing c-kit or PDGFR. Expression of these kinases will be investigated in ...
Eligibility Criteria
Inclusion
- Patients \> 18 years of age.
- Histologically documented diagnosis of one of the specified tumors, which is malignant as well as unresectable and/or metastatic and therefore, incurable with any conventional multimodality approach and immunohistochemical documentation of c-kit (CD117) or PDGFR expression in the primary tumor or metastases by tumor (preferably on a tumor sample taken within 6 week of study entry).
- At least one measurable site of disease as defined by Southwestern Oncology Group Solid Tumor Response Criteria.
- Female patients of child-bearing potential must have negative pregnancy test.
- Signed informed consent form.
- Life expectancy \>3 months.
Exclusion
- Patient has received any other investigational agents within 28 days of the first day of study drug dosing.
- Existence of any evidence of another malignant disease, except superficial non-melanoma skin cancer.
- Patient has a known brain metastases.
- Patient previously received radiotherapy to \>25% of the bone marrow.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00159016
Start Date
August 1 2002
End Date
September 1 2005
Last Update
April 28 2011
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91120