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Toremifene in desmoid tumor
2011-006205-95Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2012
- Countries
- 1
- Sponsor
- Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano
- Modality
- Small Molecules
- Drugs
- toremifene
- Conditions
- aggressive fibromatosis (AF)
01
Overview
Phase 2, open-label, single-arm trial of toremifene in aggressive fibromatosis (AF), sponsored by Fondazione IRCCS - Istituto Nazionale dei Tumori di Milano. Primary endpoints: Progression-free survival and Time to pain relief. Started Aug 2012; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Toremifene monotherapy
Adults with progressive desmoid fibromatosis treated with toremifene citrate in a single-group phase 2 design.
03
Who it enrols
Adults with histologically confirmed, measurable, progressive desmoid fibromatosis, including sporadic or familial adenomatous polyposis-associated disease, ECOG 0-2, and adequate organ function were eligible. Patients with thrombotic history, significant arrhythmia or prolonged QTc, endometrial hyperplasia, hepatic insufficiency, pregnancy, HIV infection, severe uncontrolled illness, recent investigational therapy, recent chemotherapy, or recent major surgery were excluded.
04
Endpoints
Primary
Progression-free survival
Time to pain relief
Secondary
Adverse events
Quality of life
Biomarker-response correlation
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