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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This study has been withdrawn prior to enrollment.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:
Collaborator:
Novartis
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00159016
First received: September 8, 2005
Last updated: April 27, 2011
Last verified: September 2005

September 8, 2005
April 27, 2011
August 2002
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00159016 on ClinicalTrials.gov Archive Site
Evaluate the toxicity of Glivec in patients with solid tumors.
Same as current
Not Provided
Not Provided
 
Role of Glivec in Patients With Tumor Cells Positive for C-kit or PDGFR; a Multi Center Study.
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.

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Solid Tumors.
Drug: Glivec
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
100
September 2005
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00159016
291004-HMO-CTIL
Not Provided
Not Provided
Hadassah Medical Organization
Novartis
Principal Investigator: Shimon Slavin, MD Hadassah Medical Organization
Hadassah Medical Organization
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP