Phase II Study of Imatinib Mesylate in Patients With Life Threatening Malignant Rare Diseases
1 other identifier
interventional
185
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2001
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedNovember 18, 2016
November 1, 2016
5.9 years
September 9, 2005
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Chugh R, Wathen JK, Maki RG, Benjamin RS, Patel SR, Meyers PA, Priebat DA, Reinke DK, Thomas DG, Keohan ML, Samuels BL, Baker LH. Phase II multicenter trial of imatinib in 10 histologic subtypes of sarcoma using a bayesian hierarchical statistical model. J Clin Oncol. 2009 Jul 1;27(19):3148-53. doi: 10.1200/JCO.2008.20.5054. Epub 2009 May 18.
PMID: 19451433RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Heinrich, MD
Oregon Health and Science University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 12, 2005
Study Start
February 1, 2001
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
November 18, 2016
Record last verified: 2016-11