Study to Evaluate Imatinib in Desmoid Tumors
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ClinicalTrials.gov Identifier: NCT01137916 |
Recruitment Status
:
Completed
First Posted
: June 7, 2010
Last Update Posted
: May 3, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aggressive Fibromatosis Desmoid Tumor | Drug: Imatinib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 39 participants |
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 |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: drug
Imatinib 800 mg
|
Drug: Imatinib
800 mg
Other Name: Glivec
|
- Non-progression rate after 6 months of treatment [ Time Frame: 6 months ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137916
Germany | |
University of Heidelberg, Mannheim University Medical Center | |
Mannheim, Germany, 68167 |
Principal Investigator: | Bernd Kasper, PD Dr. med. | University of Heidelberg, Mannheim University Medical Center |
Additional Information:
Responsible Party: | Bernd Kasper, PD Dr. med., Heidelberg University |
ClinicalTrials.gov Identifier: | NCT01137916 History of Changes |
Other Study ID Numbers: |
CSTI571BDE70 |
First Posted: | June 7, 2010 Key Record Dates |
Last Update Posted: | May 3, 2017 |
Last Verified: | May 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 |