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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Associazione Italiana per la Ricerca sul Cancro
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier:
NCT02353429
First received: January 28, 2015
Last updated: January 30, 2015
Last verified: January 2015
January 28, 2015
January 30, 2015
November 2012
June 2015   (Final data collection date for primary outcome measure)
Time to progression [ Time Frame: 2 years ]
This study evaluates clinical benefit by comparing sequentially measured paired failure times within each treated patient, namely time to progression after the 60 mg toremifene dose (TTP1) versus the (possibly censored) time to progression after the 180 mg toremifene dose (TTP2)
Same as current
No Changes Posted
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Toremifene in Desmoid Tumor: Prospective Clinical Trial and Identification of Potential Molecular Targets
Toremifene in Desmoid Tumor: Prospective Clinical Trial and Identification of Potential Molecular Targets

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.

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 performed at the investigators institution or after the pathological review of tissue specimen obtained via needle biopsy or surgical excision (in case of recurrence) performed elsewhere. A new biopsy will be performed if the amount of tissue will not be sufficient for immunohistochemical analysis. 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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Desmoid Type-fibromatosis
Drug: Toremifene
Patients will receive 60 mg daily and then 180 daily in case of progression
Experimental: Toremifene treatment
Patients will receive 60 mg daily of Toremifene and the dose will be escalated to 180 mg daily in case of progression
Intervention: Drug: Toremifene
Fiore M, Colombo C, Radaelli S, Callegaro D, Palassini E, Barisella M, Morosi C, Baldi GG, Stacchiotti S, Casali PG, Gronchi A. Hormonal manipulation with toremifene in sporadic desmoid-type fibromatosis. Eur J Cancer. 2015 Dec;51(18):2800-7. doi: 10.1016/j.ejca.2015.08.026. Epub 2015 Nov 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
25
December 2015
June 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients (age > 18 years) with primary or locally recurrent, sporadic or FAP associated, desmoid fibromatosis
  • Histologically documented diagnosis of DF
  • At least one measurable site of disease at CT or MRI scans, which has not been previously embolised or irradiated
  • Progressive disease demonstrated at contrast-enhanced MRI or CT scan by Response Evaluation Criteria in Solid Tumors (RECIST)
  • Radiologic or clinical evidence of PD in the previous 6 months. Radiologic PD will be defined according to RECIST
  • ECOG Performance status: 0-2
  • Prior hormonal therapy, chemotherapy, or molecular targeted therapies are allowed
  • Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN if hepatic metastases are present), creatinine < 1.5 x ULN, ANC > 1.5 x 109/L, platelets > 100 x 109/L
  • Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
  • Life expectancy of at least 6 months
  • Written, voluntary, informed consent.

Exclusion Criteria:

  • Previous history of deep vein thrombosis
  • Evidence of prolonged QTc >480 msec (using Bazetts correction, for which the formula is: QTc = QT/√RR) or history of familial long QT syndrome
  • Previous arrhythmia
  • Clinically significant bradycardia
  • Endometrial hyperplasia
  • Hepatic insufficiency
  • Other concurrent hormonal therapy, including hormonal contraceptives
  • Patient has received any other investigational agents within 28 days of first day of study drug dosing. - Female patients who are pregnant or breast-feeding
  • Patient has a severe and/or uncontrolled medical disease
  • Patient has a known diagnosis of human immunodeficiency virus (HIV) infection
  • Patient received chemotherapy within 4 weeks prior to study entry
  • Patient had a major surgery within 2 weeks prior to study entry.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT02353429
INT 112/11
No
Not Provided
Not Provided
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Associazione Italiana per la Ricerca sul Cancro
Principal Investigator: Chiara Colombo, MD Fondazione IRCCS Istituto Tumori Milano
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
January 2015

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