Overview

This trial is active, not recruiting.

Condition fibromatosis
Treatment imatinib
Phase phase 2
Targets BCR-ABL, KIT, PDGF
Sponsor Yonsei University
Start date April 2014
End date April 2017
Trial size 21 participants
Trial identifier NCT02495519, 4-2014-0074

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Imatinib 400 mg/day until disease progression
imatinib
Imatinib 400 mg/day until disease progression

Primary Outcomes

Measure
non-progressive rate
time frame: 16weeks

Secondary Outcomes

Measure
overall survival
time frame: 16 weeks

Eligibility Criteria

Male or female participants at least 10 years old.

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

Additional Information

Official title A Phase II Trial of Imatinib for Patients With Aggressive Desmoid Tumor (Aggressive Fibromatosis)
Principal investigator Hyo Song Kim
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Yonsei University.