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Completed

NCT Number: NCT00154388

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

Exploratory study 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, and to identify the contribution of specific protein tyrosine kinases (PTKs) of that specific disease.

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Key information

Conditions

Life Threatening Diseases Adenocarcinoma Adenoma Adnexal Diseases Blood Protein Disorders Bone Marrow Diseases Breast Diseases Breast Neoplasms Brenner Tumor Bronchial Neoplasms Carcinoma Carcinoma, Adenoid Cystic Carcinoma, Bronchogenic Carcinoma, Ductal Carcinoma, Ductal, Breast Carcinoma, Renal Cell Cardiovascular Diseases Chondrosarcoma Chordoma Dermatofibrosarcoma Endocrine System Diseases Endometrial Neoplasms Endometrial Stromal Tumors Eosinophilia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibroma Fibrosarcoma Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Germinoma Gonadal Disorders Hemangiopericytoma Hemangiosarcoma Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hypereosinophilic Syndrome Immune System Diseases Immunoproliferative Disorders Kidney Diseases Kidney Neoplasms Leiomyosarcoma Leukemia Leukemia, Mast-Cell Leukemia, Myeloid Leukemia, Myeloid, Acute Leukocyte Disorders Liposarcoma Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoproliferative Disorders Male Urogenital Diseases Malignant mesenchymal tumor Mast Cell Activation Disorders Mastocytosis Mastocytosis, Systemic Melanoma Mesothelioma Multiple Myeloma Myeloproliferative Disorders Myosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Adipose Tissue Neoplasms, Bone Tissue Neoplasms, Complex and Mixed Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Fibroepithelial Neoplasms, Fibrous Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Muscle Tissue Neoplasms, Nerve Tissue Neoplasms, Plasma Cell Neoplasms, Vascular Tissue Nerve Sheath Neoplasms Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Tumors Neurofibroma Neurofibrosarcoma Neuromuscular Diseases Nevi and Melanomas Osteosarcoma Ovarian Diseases Ovarian Neoplasms Paraproteinemias Peripheral Nervous System Diseases Peripheral Nervous System Neoplasms Pleural Diseases Pleural Neoplasms Primary Myelofibrosis Respiratory Tract Diseases Respiratory Tract Neoplasms Rhabdomyosarcoma Rhabdomyosarcoma, Embryonal Sarcoma Sarcoma, Endometrial Stromal Sarcoma, Ewing Sarcoma, Synovial Seminoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Small Cell Lung Carcinoma Thoracic Neoplasms Thymoma Thymus Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Diseases Uterine Neoplasms Vascular Diseases

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 discontinuation.
  • 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 initiation.
  • 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 study).
  • 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, cirrhosis).
  • 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.

Treatment and study plan

imatinib mesylate

Drug

Primary outcomes

  1. 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

  2. To identify the contribution of specific protein tyrosine kinases (PTKs) of that specific disease

Secondary outcomes

  1. To assess the safety and tolerability of Imatinib mesylate

  2. To evaluate the pharmacokinetic profile of Imatinib mesylate

  3. To assess, where feasible, the functional significance of relevant signal-transduction components in target tissues

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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