Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00159016
Status:
WITHDRAWN
Last Update Posted:
2011-04-28
First Post:
2005-09-08
Brief Title:
Role of Glivec in Patients With Tumor Cells Positive for C-kit or PDGFR a Multi Center Study
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the PI is no longer work at Hadassah
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 poday 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 800mgday
Glivec is supplied to the study investigators by Novartis Pharmaceutical Patients will receive Glivec 400mg-800mg poday 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 800mgday
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None