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Role of Glivec in Patients With Tumor Cells Positive for C-kit or PDGFR; a Multi Center Study.

This study has been withdrawn prior to enrollment.
(the PI is no longer work at Hadassah)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00159016
First Posted: September 12, 2005
Last Update Posted: April 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novartis
Information provided by:
Hadassah Medical Organization
  Purpose

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 tumor samples obtained at the time of diagnosis or from the time of recurrent disease. Every patient with positive expression of either of the kinases will be evaluated for quantitative and qualitative evidence of disease prior to entry into the study, and if possible, no other treatment will be given concomitantly, to allow evaluation of the net effect of Glivec on tumor growth kinetics, searching for measurable evidence of response.

Glivec is supplied to the study investigators by Novartis Pharmaceutical. Patients will receive Glivec 400mg-800mg p.o./day for an exposure period of up to 12 months provided that in the opinion of the investigator the patient is benefiting from treatment with Glivec, and in the absence of any safety concern. For patients with brain tumors who are not receiving concomitant enzyme inducing anti-convulsant drugs, the recommended dose of Glivec is 800mg/day.


Condition Intervention Phase
Metastatic Solid Tumors. Drug: Glivec Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Possible Role of Glivec in Patients With Tumor Cells Positive for C-kit or Platelet Derived Growth Factor Receptor (PDGFR); a Multi Center Study.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Evaluate activity of Glivec in escalating doses 400 up to 800mg/day in patients with a large variety of metastatic solid tumors expressing c-kit or PDGFR.

Secondary Outcome Measures:
  • Evaluate the toxicity of Glivec in patients with solid tumors.

Estimated Enrollment: 100
Study Start Date: August 2002
Estimated Study Completion Date: September 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00159016


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Novartis
Investigators
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
  More Information

ClinicalTrials.gov Identifier: NCT00159016     History of Changes
Other Study ID Numbers: 291004-HMO-CTIL
First Submitted: September 8, 2005
First Posted: September 12, 2005
Last Update Posted: April 28, 2011
Last Verified: September 2005

Additional relevant MeSH terms:
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action