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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.


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Solid Tumors.

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Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Principal Investigator

Shimon Slavin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Organization

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

291004-HMO-CTIL

NCT ID:

NCT00159016

Start Date:

August 2002

Completion Date:

September 2005

Related Keywords:

  • Metastatic Solid Tumors.

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