- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00159016
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.
Study Overview
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Jerusalem, Israel, 91120
- Hadassah Medical Organization
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
Evaluate the toxicity of Glivec in patients with solid tumors.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shimon Slavin, MD, Hadassah Medical Organization
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 291004-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metastatic Solid Tumors.
-
Incyte CorporationRecruitingA Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors | Solid Tumors | Metastatic Solid TumorsUnited States, Spain, United Kingdom, France, Italy, Denmark, Switzerland
-
Genentech, Inc.RecruitingAdvanced Solid Tumors | Metastatic Solid TumorsCanada, Korea, Republic of, United States, Brazil, Australia, Argentina, Spain, New Zealand, Poland
-
Incyte Biosciences Japan GKCompletedAdvanced Solid Tumors | Metastatic Solid TumorsJapan
-
Memorial Sloan Kettering Cancer CenterKyowa Hakko Kirin Pharma, Inc.CompletedAdvanced Solid Tumors | Metastatic Solid TumorsUnited States
-
Bristol-Myers SquibbCompletedAdvanced Solid Tumors | Metastatic Solid TumorsKorea, Republic of, Canada, Australia
-
University of AlbertaWithdrawnLocally Advanced Solid Tumors | Metastatic Solid TumorsCanada
-
NeuPharma, Inc.RecruitingLocally Advanced Solid Tumors | Metastatic Solid TumorsUnited States
-
Alphamab (Australia) Co Pty Ltd.RecruitingAdvanced Solid Tumors | Metastatic Solid TumorsAustralia
-
Jiangsu Simcere Pharmaceutical Co., Ltd.UnknownAdvanced Solid Tumors | Metastatic Solid TumorsChina
-
EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyCompleted
Clinical Trials on Glivec
-
Novartis PharmaceuticalsCompletedUrogenital Neoplasms | Genital Neoplasms, Male | Prostatic Diseases | Antineoplastic Agents | Imatinib | Prostatic Neoplasm | Genital Diseases, Male | Neoplasms, AbdominalGermany
-
University of AarhusCompletedNephrogenic Systemic FibrosisDenmark
-
Chong Kun Dang PharmaceuticalCompletedGastrointestinal Stromal Tumors | Chronic Myeloid LeukemiaKorea, Republic of
-
Samyang Biopharmaceuticals CorporationSeverance HospitalCompleted
-
PETHEMA FoundationCompleted
-
Novartis PharmaceuticalsNo longer availableGastrointestinal Stromal TumorChina
-
Central European Cooperative Oncology GroupCompletedGastrointestinal Stromal TumorsCroatia, Bosnia and Herzegovina, Romania, Slovakia, Bulgaria, Czech Republic, Austria, Lithuania, Serbia, Slovenia
-
Hikma Pharmaceuticals LLCRecruiting
-
Professor Mikael Svensson, MD PhDUnknownCervical Spinal Cord Injury
-
Università degli Studi di BresciaCompleted