Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00171912
First received: September 13, 2005
Last updated: November 29, 2012
Last verified: November 2012
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Purpose
This trial is for various types of malignancies which may depend on certain enzymes (tyrosine kinases) for growth. The objective of this study is to assess to what extent imatinib mesylate blocks these enzymes and to assess the effect on the malignancy.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypereosinophilic Syndrome Systemic Mastocytosis Chronic Myelomonocytic Leukemia Dermatofibrosarcoma |
Drug: imatinib mesylate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Imatinib Mesylate in Patients With Various Types of Malignancies Involving Activated Tyrosine Kinase Enzymes |
Resource links provided by NLM:
Genetics Home Reference related topics:
dermatofibrosarcoma protuberans
PDGFRA-associated chronic eosinophilic leukemia
PDGFRB-associated chronic eosinophilic leukemia
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- To assess the efficacy and the safety of imatinib mesylate therapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the effects of imatinib on quality of life and healthcare resource use [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 38 |
| Study Start Date: | September 2004 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: imatinib mesylate (STI571) |
Drug: imatinib mesylate
Other Name: STI571
|
Detailed Description:
Condition
Diverse malignancies either associated with or thought to be associated with activated tyrosine kinase enzymes including hypereosinophilic syndrome systemic mastocytosis chronic myelomonocytic leukaemia, dermatofibrosarcoma protuberans and other diseases.
Not included:
Patients with chronic myeloid leukemia, some other types of leukemias (abl-mutated) some types of gastrointestinal stromal tumours (c-KIT-positive), some systemic mastocytosis (if c-KIT D816V mutation), brain, prostate, breast or lung cancers.
Eligibility| Ages Eligible for Study: | 16 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Malignancy likely related to an activated tyrosine kinase enzyme sensitive to imatinib mesylate.
- Spread of the disease to the rest of the body (confirmed by tissue sample) beyond the skin.
- Malignant tissue showing activation of certain tyrosine kinases (ABL, ARG, KIT (CD117), or PDGF-R alpha or beta) & preferably within 6 weeks of entry.
Exclusion Criteria:
- Certain leukaemias (abl-mutated), some gastrointestinal stromal tumours (c-KIT-positive) or certain systemic mastocytosis (if c- KIT D816V mutation).
- A primary prostate, breast, lung or brain tumour,
- Patient has previously been treated with imatinib mesylate except where treatment was more than 6 months previously and there is no suggestion of clinical resistance nor lack of response.
Other protocol-defined inclusion / exclusion criteria may apply.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00171912 History of Changes |
| Other Study ID Numbers: | CSTI571BAU12 |
| Study First Received: | September 13, 2005 |
| Last Updated: | November 29, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Novartis:
|
Imatinib mesylate tyrosine kinases imatinib sensitivity Diverse malignancies either associated with or thought to be associated with activated tyrosine kinase enzymes including hypereosinophilic syndrome systemic mastocytosis chronic myelomonocytic leukaemia, |
dermatofibrosarcoma protuberans and other diseases. Not included: patients with chronic myeloid leukemia, some other types of leukemias (abl-mutated) some types of gastrointestinal stromal tumours (c-KIT-positive), some systemic mastocytosis (if c-KIT D816V mutation), brain, prostate, breast or lung cancers. |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Leukemia, Myelomonocytic, Chronic Mastocytosis Urticaria Pigmentosa Mastocytoma Leukemia, Myelomonocytic, Acute Hypereosinophilic Syndrome Dermatofibrosarcoma Mastocytosis, Systemic Neoplasms by Histologic Type Leukemia, Myeloid Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Hematologic Diseases |
Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin Diseases Mastocytosis, Cutaneous Pigmentation Disorders Eosinophilia Leukocyte Disorders Fibrosarcoma Neoplasms, Fibrous Tissue Sarcoma Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013