At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 15 enrolled
Drug / intervention
50 mg/m2 aldoxorubicin +2 moredrug
Likely dose
50–150 mg/m² aldoxorubicin intravenouslyAI-extracted
Key inclusion· 7
- ✓Age ≥18 years
- ✓HIV-positive confirmed by ELISA and western blot, with histologically confirmed Kaposi's sarcoma
- ✓Measurable tumor lesions at accessible site or by radiography per ACTG TIS criteria
- ✓KPS ≥70
Key exclusion· 10
- ✕Prior exposure to an anthracycline
- ✕Surgery and/or radiation treatment <4 weeks prior to randomization
- ✕Exposure to any investigational agent within 30 days of randomization
- ✕History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer, or carcinoma in situ of cervix) unless documented free of cancer for ≥3 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Pilot Phase 2 Study to Investigate Efficacy, Safety, and Intratumoral Kinetics of ALDOXORUBICIN in HIV-Infected Patients With Kaposi's Sarcoma
In Brief
A Phase 2 clinical trial evaluating 50 mg/m2 aldoxorubicin, 100 mg/m2 aldoxorubicin, and 1 other intervention for Kaposi's Sarcoma and 2 related conditions. Completed, enrolled 15 participants across 1 site.
Detailed Summary
This is a pilot study to determine the efficacy, kinetics and safety of aldoxorubicin in HIV positive subjects with Kaposi's sarcoma.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKaposi's Sarcoma, HIV Positive, AIDS
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 2014
Enrollment StartApr 2014
Primary CompletionApr 2016
TodayJul 2026
First PostedJan 7, 2014
Enrollment StartApr 3, 2014
Primary CompletionApr 25, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.5 years ago
Interventions
50 mg/m2 aldoxorubicindrug
100 mg/m2 aldoxorubicindrug
150 mg/m2 aldoxorubicindrug