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A Phase II Study of sEphB4-HSA in Kaposi Sarcoma
sEphB-HSA may prevent tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor. The purpose of this study is to learn if sEphB4-HSA will decrease the number or size of Kaposi sarcoma lesions in people.
Details
| Lead sponsor | Vasgene Therapeutics, Inc |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 65 |
| Start date | 2020-09-17 |
| Completion | 2025-06 |
Conditions
- Kaposi Sarcoma
Interventions
- sEphB4-HSA
Primary outcomes
- Evaluate the change in clinical response and toxicity of sEphB4-HSA at 10 mg/kg every 2 weeks in participants with KS. — Every 4 weeks until study completion (average 6 months).
The observed proportions of participants experiencing clinical response and unacceptable toxicity will be calculated with 95% confidence intervals. For clinical response, the Kaplan-Meier method will be used to estimate the distribution for time to death assessed for up to 1 month after treatment completion; for time to progression assessed from chemotherapy initiation to first documented progression up to 1 month after treatment completion; and for time to response assessed from the first dose until first documented response up to 1 month after completion of treatment. The Kaplan-Meier method will then be used to estimate the distribution of time to response, time to relapse, and time to death. Adverse events will be tabulated according to type and severity.
Countries
United States