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Phase II Study of Imatinib Mesylate in Patients With Life Threatening Malignant Rare Diseases
This study has been completed.
Study NCT00154388   Information provided by Novartis
First Received: September 9, 2005   Last Updated: September 21, 2009   History of Changes

September 9, 2005
September 21, 2009
February 2001
 
  • 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
  • To identify the contribution of specific protein tyrosine kinases (PTKs) of that specific disease
Same as current
Complete list of historical versions of study NCT00154388 on ClinicalTrials.gov Archive Site
  • To assess the safety and tolerability of Imatinib mesylate
  • To evaluate the pharmacokinetic profile of Imatinib mesylate
  • To assess, where feasible, the functional significance of relevant signal-transduction components in target tissues
Same as current
 
Phase II Study of Imatinib Mesylate in Patients With Life Threatening Malignant Rare Diseases
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.

 
Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Life Threatening Diseases
Drug: Imatinib mesylate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
191
 
 

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.

Both
15 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00154388
 
CSTI571B2225
Novartis
 
Principal Investigator: Michael Heinrich, MD Oregon Health and Science University
Novartis
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP