Phase 3 Study to Treat Patients With Soft Tissue Sarcomas
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|ClinicalTrials.gov Identifier: NCT02049905|
Recruitment Status : Completed
First Posted : January 30, 2014
Last Update Posted : June 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metastatic, Locally Advanced or Unresectable Soft Tissue Sarcoma||Drug: Aldoxorubicin Drug: Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||433 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Randomized, Open-Label Phase 3 Study to Investigate the Efficacy and Safety of Aldoxorubicin Compared to Investigator's Choice in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcomas Who Either Relapsed or Were Refractory to Prior Non-Adjuvant Chemotherapy|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
Aldoxorubicin is administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously on Day 1 every 21-day cycles until tumor progression or unacceptable toxicity occurs.
Other Name: INNO-206
Active Comparator: Investigator's Choice of Treatment
These treatments include:
Drug: Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)
- Progression-Free Survival (PFS) [ Time Frame: 24 months ]PFS is defined as the time from the date of randomization 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 (OS) [ Time Frame: 36 months ]Overall survival is defined as the time from randomization 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.
- Safety Measures [ Time Frame: 24 months ]The safety of aldoxorubicin compared to investigator's choice in this population assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiogram (ECHO) evaluations, electrocardiogram (ECG) results, and weight, as well as disease control rate and tumor response.
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): NCT02049905