Preliminary Efficacy and Safety of INNO-206 Compared to Doxorubicin in Advanced Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT01514188|
Recruitment Status : Unknown
Verified September 2013 by CytRx.
Recruitment status was: Active, not recruiting
First Posted : January 23, 2012
Last Update Posted : September 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Soft Tissue Sarcoma Locally Advanced Soft Tissue Sarcoma Unresectable Soft Tissue Sarcoma||Drug: INNO-206 Drug: Doxorubicin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||April 2014|
|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
- Progression-free survival [ Time Frame: Over the duration of the trial, approximately 24 months ]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. ]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 ]
- Objective overall response rate (ORR) [ Time Frame: Approximately 24 months. ]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. ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514188
|Principal Investigator:||Sant Chawla, M.D.||Sarcoma Oncology Center|
|Study Director:||Daniel Levitt, M.D., Ph.D.||CytRx|