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 Maximum Tolerated Dose of the combination was determined and the Phase I terminated.
Then, Phase II study started.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: Maximum Tolerated Dose (MTD) of combination of TLC D-99 and Ifosfamide
Definition of TDL
Armando Santoro, MD
Istituto Clinico Humanitas
Italy: Ministry of Health