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Phase II Study of Imatinib Mesylate in Patients With Life Threatening Malignant Rare Diseases

Phase 2
15 Years
70 Years
Not Enrolling
Life Threatening Diseases

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Trial Information

Phase II Study of Imatinib Mesylate in Patients With Life Threatening Malignant Rare Diseases

Inclusion Criteria:

- Patients ≥ 15 years of age

- Life threatening disease documented by conventional criteria to be resistant to
standard, approved therapy.

- Experimental documentation of functional significance of either Abl, Kit (CD117), or
PDGF-R in the relevant target tissue (preferably on a sample taken within 6 weeks of
study entry).

- ECOG Performance status of 0, 1, or 2.

- Adequate end organ function defined as: total bilirubin < 1.5 x ULN, SGOT and SGPT <
2.5 x UNL (or < 5 x ULN for patients with hepatic disease), creatinine < 1.5 x ULN,
ANC > 1.5 x 109/L, platelets > 100 x 109/L.

- Negative serum or urine pregnancy test for women of child bearing potential (WOCBP)
within 7 days of study initiation. Post menopausal women must have experienced
amenorrhea for at least 12 months. Male and female patients must use effective birth
control methods throughout the study and for up to 3 months after study

- Life expectancy of more than 3 months.

- Written, voluntary, informed consent for retrieval, evaluation and investigational
use of tissue samples.

Exclusion Criteria:

- Patients who have received any other investigational agent within 28 days of study

- Patients with another primary malignancy except if other primary malignancy is
neither currently clinically significant nor requiring active intervention.

- Patients with Grade III/IV cardiac problems defined by the New York Heart Association
Criteria (e.g. congestive heart failure, myocardial infarction within 6 months of

- Female patients who are pregnant or breast-feeding.

- Patients who have another severe and/or life threatening medical disease.

- Patients with acute or known chronic liver disease (e.g. chronic active hepatitis,

- Patients with a known diagnosis of the human immunodeficiency virus ((HIV) infection.

- Patients who have received chemotherapy within 4 weeks (6 weeks allowed for
nitrosourea, mitomycin-C or any antibody therapy) prior to study entry.

- Patients who have had major surgery within 2 weeks prior to study entry.

- Patients with any significant history of non-compliance to medical regimens or with
inability to grant reliable informed consent.

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To examine the effect(s) of Imatinib mesylate treatment on life threatening rare diseases with known associations to one or more Imatinib mesylate-sensitive tyrosine kinases

Principal Investigator

Michael Heinrich, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Science University


United States: Food and Drug Administration

Study ID:




Start Date:

February 2001

Completion Date:

January 2007

Related Keywords:

  • Life Threatening Diseases
  • adenocarcinoma
  • leiomyosarcoma
  • angiosarcoma
  • synovial sarcoma
  • myelodysplastic syndrome/HES
  • CMML
  • multiple myeloma
  • embryonal rhabdomyosarcoma
  • endometrial sarcoma
  • adenoid cystic carcinoma
  • fibromatosis
  • ductal invasive breast carcinoma
  • chondrosarcoma
  • pleural tumor
  • brenner tumor
  • ewing sarcoma
  • round cell tumor
  • seminoma
  • thymic carcinoma
  • malignant melanoma
  • fibrosarcoma breast
  • dermatofibrosarcoma protuberans
  • DFSP
  • ovarian stromal tumor
  • osteosarcoma
  • chorioideal melanoma
  • hemangiopericytoma
  • myelofibrosis
  • liposarcoma
  • SCLC
  • small cell lung carcinoma
  • hypereosinophilic syndrome
  • chronic myelo-monocytic leukemia
  • neurofibrosarcoma
  • mesothelioma
  • malignant mesenchymoma
  • malignant schwannoma
  • mast cell leukemia / mastocytosis
  • renal cell carcinoma
  • malignant histocytoma
  • chordoma
  • Rare Diseases