At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 70 enrolled
Drug / intervention
170 mg/m2 aldoxorubicin +1 moredrug
Likely dose
170 mg/m2 aldoxorubicinfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Phase 1/2 Study to Investigate the Preliminary Safety and Activity of Aldoxorubicin Plus Ifosfamide/Mesna in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma
In Brief
A Phase 2 clinical trial evaluating 170 mg/m2 aldoxorubicin and 250 mg/m2 aldoxorubicin for Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma. Completed, enrolled 70 participants across 1 site.
Detailed Summary
This is a Phase 1 open-label study to study the safety and activity of aldoxorubicin with ifosfamide/mesna in subjects with metastatic, advanced, unresectable soft tissue sarcoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartSep 2014
First PostedSep 2014
Primary CompletionMay 2018
TodayJul 2026
First PostedSep 10, 2014
Enrollment StartSep 2, 2014
Primary CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.8 years ago
Interventions
170 mg/m2 aldoxorubicindrug
administered at 170 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
250 mg/m2 aldoxorubicindrug
administered at 250 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days