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Study to Evaluate Imatinib in Desmoid Tumors
This study has been completed.
Sponsor:
Heidelberg University
Collaborator:
Novartis
Information provided by (Responsible Party):
Bernd Kasper, Heidelberg University
ClinicalTrials.gov Identifier:
NCT01137916
First received: June 2, 2010
Last updated: May 2, 2017
Last verified: May 2017
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Purpose
The objective of the present study is to evaluate the activity and safety of imatinib in patients with aggressive fibromatosis who, after receiving the standard therapy, show an inoperable recurrent tumor or disease not readily controllable by surgery or radiotherapy.
| Condition | Intervention | Phase |
|---|---|---|
| Aggressive Fibromatosis Desmoid Tumor | Drug: Imatinib | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Phase II Study to Evaluate Glivec (Imatinib Mesylate) to Induce Progression Arrest in Aggressive Fibromatosis / Desmoid Tumors Not Amenable to Surgical Resection With R0 Intent or Accompanied by Unacceptable Function Loss |
Resource links provided by NLM:
Further study details as provided by Bernd Kasper, Heidelberg University:
Primary Outcome Measures:
- Non-progression rate after 6 months of treatment [ Time Frame: 6 months ]
Secondary Outcome Measures:
- Non-progression rate after 12 and 24 months of treatment [ Time Frame: 12 and 24 months ]
- Response rate [ Time Frame: 12 and 24 months ]
- Progression-free survival (PFS) and overall survival (OS) [ Time Frame: 12 and 24 months ]
- Recording of patient quality of life [ Time Frame: 12 and 24 months ]
| Enrollment: | 39 |
| Study Start Date: | June 2010 |
| Study Completion Date: | December 2016 |
| Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: drug
Imatinib 800 mg
|
Drug: Imatinib
800 mg
Other Name: Glivec
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with histological confirmed aggressive fibromatosis (desmoid tumor)
- Measurable disease according to the RECIST criteria
- Evidence of relapse or disease progression within the last 6 months (based on RECIST criteria) in computed tomography or magnetic resonance imaging
- No possibility of complete surgical resection or cases in which surgical therapy leaving a large tissue defect, functional deficit or disfigurement would be required
- No possibility of curative radiotherapy with acceptable toxicity and/or late morbidity
- Previous treatment of the tumor region by surgical intervention and/or radiotherapy and/or antihormonal therapy possible
- Age > or = 18 years
- WHO PS < or = 1
- Effective contraception during study medication
- Signed informed consent form
Exclusion Criteria:
- Surgical intervention < 4 weeks
- Prior therapy with imatinib
- Pregnancy or lactation
- Severe hepatic dysfunction
- Known allergic reaction to imatinib or one of its components
- The following laboratory values: Absolute neutrophil count < 1.5 x 103/mm3, Platelets < 100,000/mm3, Serum creatinine > or = 2.5 mg/dl, SGOT and/or SGPT > 2.5 x ULN (upper limit of normal), Total bilirubin > 1.5 x ULN
- Participation in another study (four weeks before and during the study)
- Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01137916
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137916
Locations
| Germany | |
| University of Heidelberg, Mannheim University Medical Center | |
| Mannheim, Germany, 68167 | |
Sponsors and Collaborators
Heidelberg University
Novartis
Investigators
| Principal Investigator: | Bernd Kasper, PD Dr. med. | University of Heidelberg, Mannheim University Medical Center |
More Information
Additional Information:
| Responsible Party: | Bernd Kasper, PD Dr. med., Heidelberg University |
| ClinicalTrials.gov Identifier: | NCT01137916 History of Changes |
| Other Study ID Numbers: |
CSTI571BDE70 |
| Study First Received: | June 2, 2010 |
| Last Updated: | May 2, 2017 |
Additional relevant MeSH terms:
|
Aggression Fibromatosis, Aggressive Fibroma Behavioral Symptoms Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Imatinib Mesylate Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on August 22, 2017