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Toremifene in Desmoid Tumor: Prospective Clinical Trial and Identification of Potential Molecular Targets

NCT02353429 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-02-02

No results posted yet for this study

Summary

This is a prospective study evaluating the activity and the safety of toremifene in patients with primary or recurrent sporadic DTs.

Patients will be enrolled after the histological confirmation of DTs on biopsy Patients will start at 60 mg daily and dose-escalate to 180 mg upon progression. Disease assessment will be performed by contrast-enhanced MRI or CT scan, pain evaluation by a visual analog scale (VAS) every 3 months for the first and second year, twice yearly thereafter. Response will be evaluated either by RECIST and/or symptomatic relief.

Conditions

  • Desmoid Type-fibromatosis

Interventions

DRUG

Toremifene

Patients will receive 60 mg daily and then 180 daily in case of progression

Sponsors & Collaborators

  • Associazione Italiana per la Ricerca sul Cancro

    collaborator OTHER

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Chiara Colombo, MD · Fondazione IRCCS Istituto Tumori Milano

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-06-30
Completion
2015-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02353429 on ClinicalTrials.gov