At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 433 enrolled
Drug / intervention
Aldoxorubicin +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
- ✓Histological confirmation of intermediate or high grade soft-tissue sarcoma
- ✓Locally advanced, unresectable, and/or metastatic soft-tissue sarcoma with evidence of disease progression within 6 months prior to randomization
- ✓Relapsed or refractory to ≥1 course of systemic therapy regimen(s), excluding adjuvant or neoadjuvant chemotherapy
- ✓Age ≥15 years (US only), 18-80 years (rest of world)
Key exclusion· 9
- ✕Prior exposure to >375 mg/m² of doxorubicin or liposomal doxorubicin
- ✕Palliative surgery and/or radiation treatment within 30 days prior to randomization
- ✕Exposure to any systemic chemotherapy within 30 days prior to randomization
- ✕Current evidence/diagnosis of alveolar soft part sarcoma, extraskeletal myxoid chondrosarcoma, rhabdomyosarcoma, osteosarcoma, gastrointestinal stromal tumor (GIST), dermatofibrosarcoma (unless transformed to fibrosarcoma), Ewing's sarcoma, Kaposi's sarcoma, mixed mesodermal tumor, or clear cell sarcomas
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Aldoxorubicin and Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide) for Metastatic, Locally Advanced or Unresectable Soft Tissue Sarcoma. Completed, enrolled 433 participants across 74 sites in 13 countries.
Detailed Summary
The purpose of this study is to determine the efficacy and safety of aldoxorubicin in subjects with metastatic, locally advanced, or unresectable soft tissue sarcomas.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, Chile, Denmark, France, Hungary, Israel, Italy, Netherlands, Poland, Russia, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJan 2014
First PostedJan 2014
Primary CompletionMay 2017
TodayJul 2026
First PostedJan 30, 2014
Enrollment StartJan 1, 2014
Primary CompletionMay 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 12.4 years ago
Interventions
Aldoxorubicindrug
Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)drug