Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma
This is a phase 2b, randomized, open-label, prospective, multicenter study comparing treatment with INNO 206 to doxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas who have not been previously treated with any chemotherapy except potentially as adjuvant or neoadjuvant chemotherapy, and no evidence of tumor recurrence has occurred for at least 12 months.
Metastatic Soft Tissue Sarcoma
Locally Advanced Soft Tissue Sarcoma
Unresectable Soft Tissue Sarcoma
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Progression-free survival [ Time Frame: Over the duration of the trial, approximately 24 months ] [ Designated as safety issue: No ]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.
- Overall Survival [ Time Frame: Approximately 36 months. ] [ Designated as safety issue: No ]Survival is defined as the time from enrollment to date of death. In the absence of confirmation of death, survival time will be censored at the last date the subject is known to be alive.
- Progression-free survival at 4 and 6 months [ Time Frame: Month 4 and 6 ] [ Designated as safety issue: No ]
- Objective overall response rate (ORR) [ Time Frame: Approximately 24 months. ] [ Designated as safety issue: No ]The overall tumor response rate is defined as the total proportion of subjects who have an objective tumor response (CR + PR).
- Safety measures. [ Time Frame: Approximately 24 months. ] [ Designated as safety issue: Yes ]Adverse events, Ability to remain on assigned treatment (tolerability), Clinical and laboratory data including physical examinations, vital signs, weight, MUGA/cardiac ultrasound evaluations, ECG results and laboratory test results, Use of concomitant medications
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Doxorubicin||
Doxorubicin administered at 75 mg/m2 for up to 6 consecutive cycles.
INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles
Other Name: DOXO-EMCH
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).
Show 34 Study Locations
|Principal Investigator:||Sant Chawla, M.D.||Sarcoma Oncology Center|
|Study Director:||Daniel Levitt, M.D., Ph.D.||CytRx|