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A Perspective Phase I and II Trial of Liposome-encapsulated Doxorubicin (TLC D-99) in Combination With Ifosfamide in Patients With Metastatic Soft Tissue Sarcoma
The purpose of this study is to determine the maximum tolerated dose of the TLC D-99 combined with ifosfamide and then the efficacy of this combination in terms of overall response rate, time to progression and time of response
Details
| Lead sponsor | Istituto Clinico Humanitas |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 36 |
| Start date | 2006-09 |
| Completion | 2009-12 |
Conditions
- Sarcoma, Soft Tissue
Interventions
- combination of TLC D-99 and Ifosfamide
Primary outcomes
- Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide — Definition of TDL
- Phase II: Response rate (CR/PR or SD) — Tumor assessment
Countries
Italy