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A Trial of Imatinib for Patients With Aggressive Desmoid Tumor (Aggressive Fibromatosis)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02495519
Recruitment Status : Completed
First Posted : July 13, 2015
Last Update Posted : January 14, 2020
Information provided by (Responsible Party):
Hyo Song Kim, Yonsei University

Brief Summary:
Aggressive fibromatosis (AF, also known as desmoid tumor) is a fibroproliferative neoplasm that typically arises in the abdomen but can develop at other anatomic sites, most commonly in the extremities. These tumors have a relatively high local failure rate after primary treatment using surgery and/or radiotherapy, and although rarely giving rise to distant metastases, can be multifocal and, therefore, not surgically resectable. Moreover, tumor may recur adjacent to the site of surgical resection, underscoring the limitations of surgery in the palliative setting. Therefore, effective medical therapies for AF are needed to maintain quality of life and prolong survival.The goal of the current study was to better define the activity of imatinib in the treatment of AF and to determine the molecular basis for response/nonresponse

Condition or disease Intervention/treatment Phase
Fibromatosis Drug: Imatinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Imatinib for Patients With Aggressive Desmoid Tumor (Aggressive Fibromatosis)
Study Start Date : April 2014
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: imatinib
Imatinib 400 mg/day until disease progression
Drug: Imatinib
Imatinib 400 mg/day until disease progression

Primary Outcome Measures :
  1. non-progressive rate [ Time Frame: 16weeks ]
    non-progressive rate at 16weeks

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Written consent;
  2. Age ≥ 10 years;
  3. Eastern Cooperative Oncology Group Performance status ≤ 2;
  4. Histologically confirmed desmoid tumor;
  5. Disease progression after local treatment
  6. Measurable target lesion (RECIST criteria) ;
  7. Adequate hematological, renal and liver functions :

Exclusion Criteria:

  1. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
  2. Pregnant or lactating female
  3. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study

Information from the National Library of Medicine

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 identifier (NCT number): NCT02495519

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Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
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Principal Investigator: Hyo Song Kim Severance Hospital, Yonsei University Health System
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Responsible Party: Hyo Song Kim, Clinical Associate Professor, Yonsei University Identifier: NCT02495519    
Other Study ID Numbers: 4-2014-0074
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Fibromatosis, Aggressive
Behavioral Symptoms
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action