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

Phase 2

Completed

• Conditions: Fibromatosis
• Interventions: Drug: Imatinib

• Registration Number: NCT02495519
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-13
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
imatinib	Imatinib	Imatinib 400 mg/day until disease progression

Primary Outcome Measures

Name	Time	Method
non-progressive rate	16weeks	non-progressive rate at 16weeks

Secondary Outcome Measures

Name	Time	Method
overall survival	16 weeks

Trial Locations

Locations (1)

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of