At a glance
ClinicalIndex Comparison Record- ✓Age 15–80 years (US) or 18–80 years (rest of world)
- ✓Histologically or cytologically confirmed metastatic, locally advanced, or unresectable soft tissue sarcoma of intermediate or high grade
- ✓ECOG performance status 0–2
- ✓Life expectancy >12 weeks
- ✕Prior chemotherapy other than adjuvant/neoadjuvant (or if prior adjuvant/neoadjuvant with recurrence <12 months)
- ✕Prior exposure to >3 cycles or >225 mg/m² of doxorubicin or Doxil
- ✕Palliative surgery or radiation within 4 weeks before randomization
- ✕Investigational agent exposure within 30 days of randomization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating INNO-206 and Doxorubicin for Metastatic Soft Tissue Sarcoma and 2 related conditions. Completed, enrolled 126 participants across 34 sites in 7 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
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
Doxorubicin administered at 75 mg/m2 for up to 6 consecutive cycles.