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

Primary Purpose

Life Threatening Diseases

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Imatinib mesylate
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Life Threatening Diseases focused on measuring 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

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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 Outcome Measures

    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

    Full Information

    First Posted
    September 9, 2005
    Last Updated
    November 16, 2016
    Sponsor
    Novartis Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00154388
    Brief Title
    Phase II Study of Imatinib Mesylate in Patients With Life Threatening Malignant Rare Diseases
    Official Title
    Phase II Study of Imatinib Mesylate in Patients With Life Threatening Malignant Rare Diseases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2001 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    January 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Novartis Pharmaceuticals

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Life Threatening Diseases
    Keywords
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    185 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Imatinib mesylate
    Primary Outcome Measure Information:
    Title
    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
    Title
    To identify the contribution of specific protein tyrosine kinases (PTKs) of that specific disease
    Secondary Outcome Measure Information:
    Title
    To assess the safety and tolerability of Imatinib mesylate
    Title
    To evaluate the pharmacokinetic profile of Imatinib mesylate
    Title
    To assess, where feasible, the functional significance of relevant signal-transduction components in target tissues

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Heinrich, MD
    Organizational Affiliation
    Oregon Health and Science University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19451433
    Citation
    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. Erratum In: J Clin Oncol. 2009 Sep 20;27(27):4630. Myers, Paul A [corrected to Meyers, Paul A].
    Results Reference
    result

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

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