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Trabectedin vs Dacarbazine in Advanced Liposarcoma or Leiomyosarcoma
NCT01343277Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2011
- Primary completion
- Jan 2015
- Countries
- 4
- Sponsor
- Janssen Pharmaceutical
- Modality
- Covalent Small Molecules, Classical Binding Small Molecules, Nucleic Acid-Directed Small Molecules
- Drugs
- trabectedin
- Conditions
- Liposarcomaleiomyosarcoma (LMS)
01
Overview
Phase 3, randomised, open-label trial of trabectedin in Liposarcoma and leiomyosarcoma (LMS) (2 arms), sponsored by Janssen Pharmaceutical. Primary endpoint: Overall Survival. Started Jun 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Trabectedin
Trabectedin 1.5 mg/m2 IV infusion over 24 hours every 3 weeks
Dacarbazine
Dacarbazine 1.0 g/m2 IV infusion over 20-120 minutes every 3 weeks
03
Who it enrols
Patients with histologically proven, unresectable, locally advanced or metastatic liposarcoma or leiomyosarcoma who have been previously treated with an anthracycline and ifosfamide containing regimen.
04
Endpoints
Primary
Overall Survival
Secondary
Progression-Free Survival
Time to Progression
Objective Response Rate
Duration of Response
Adverse Events
05
Results
Not all primary endpoints met
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