A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma
One hundred five subjects will be enrolled and randomized 2:1 to receive either INNO-206 or
doxorubicin. INNO-206 at a dosage of 350 mg/m2 (doxorubicin equivalents of 260 mg/m2) will
be administered as a 30 minute IVI on Day 1 of each cycle to approximately 70 subjects.
Doxorubicin (75 mg/m2) will be administered to approximately 35 subjects on Day 1 of each
cycle. An individual cycle of therapy will be defined as a 3-week (21-day) period. Cycles
will be repeated every 3 weeks. Multiple cycles may be administered until the subject is
withdrawn from therapy or until a maximum of 6 cycles are administered. Overall response
rates as well as individual categories of response (CR, PR, SD, and PD) will be determined
using RECIST 1.1. Time-to-event endpoints, including PFS and OS will be assessed using
the Kaplan Meier method. Evaluation of 4- and 6-month progression-free survival will
also be performed. Toxicity (adverse events) will be recorded using the NCI CTCAE, version
4.0 (published 28 May 2009).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS) is defined as the time from enrollment to first documentation of objective tumor progression or to death due to any cause in the absence of previous documentation of objective tumor progression.
Over the duration of the trial, approximately 24 months
Sant Chawla, M.D.
Sarcoma Oncology Center
United States: Food and Drug Administration
|University of Iowa||Iowa City, Iowa 52242|
|Stanford University||Stanford, California 94305|
|Sarcoma Oncology Center||Santa Monica, California 90403|
|Pennsylvania Hematology Oncology Associates||Philadelphia, Pennsylvania 19106|
|CTRC Institute for Drug Development, University of Texas||San Antonio, Texas 78229-3900|