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

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ClinicalTrials.gov Identifier: NCT02495519
Recruitment Status : Completed
First Posted : July 13, 2015
Last Update Posted : June 27, 2018
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
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 ]


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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02495519


Locations
Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Hyo Song Kim Severance Hospital, Yonsei University Health System

Responsible Party: Hyo Song Kim, Clinical Associate Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT02495519     History of Changes
Other Study ID Numbers: 4-2014-0074
First Posted: July 13, 2015    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Aggression
Fibromatosis, Aggressive
Fibroma
Behavioral Symptoms
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action