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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02495519
First Posted: July 13, 2015
Last Update Posted: July 13, 2016
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.
Information provided by (Responsible Party):
Hyo Song Kim, Yonsei University
July 8, 2015
July 13, 2015
July 13, 2016
April 2014
April 2017   (Final data collection date for primary outcome measure)
non-progressive rate [ Time Frame: 16weeks ]
non-progressive rate at 16weeks
Same as current
Complete list of historical versions of study NCT02495519 on ClinicalTrials.gov Archive Site
overall survival [ Time Frame: 16 weeks ]
Same as current
Not Provided
Not Provided
 
A Trial of Imatinib for Patients With Aggressive Desmoid Tumor (Aggressive Fibromatosis)
A Phase II Trial of Imatinib for Patients With Aggressive Desmoid Tumor (Aggressive Fibromatosis)
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
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Fibromatosis
Drug: Imatinib
Imatinib 400 mg/day until disease progression
Experimental: imatinib
Imatinib 400 mg/day until disease progression
Intervention: Drug: Imatinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
21
December 2017
April 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
10 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT02495519
4-2014-0074
No
Not Provided
Not Provided
Hyo Song Kim, Yonsei University
Yonsei University
Not Provided
Principal Investigator: Hyo Song Kim Severance Hospital, Yonsei University Health System
Yonsei University
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP