Ignite Creation Date:
2025-12-26 @ 5:17 PM
Ignite Modification Date:
2026-01-01 @ 5:49 AM
Study NCT ID:
NCT03993106
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2019-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of sEphB4-HSA in Kaposi Sarcoma
Sponsor:
Vasgene Therapeutics, Inc
Organization:
Study Overview
Official Title:
A Phase II Study of sEphB4-HSA in Kaposi Sarcoma
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
sEphB4-HSA will be given through an intravenous infusion (into a vein). Each cycle of sEphB4-HSA will be 28 days (4 weeks). Each cycle of the study drug includes administration of 2 doses of sEphB4-HSA given on Days 1 and 15 of each cycle.
Participants may continue on study protocol as long as their KS is continuing to respond or is clinically stable on study medication.
Patients may come off treatment for the following reasons:
* Disease progression.
* Need for more than 2 dose reductions for toxicity.
* Dose delay more than 28 days.
* Patient withdraws consent.
* Study termination by the Sponsor.
* Participants who are noncompliant with respect to taking drugs, keeping appointments, or having tests required for the evaluation of drug safety and efficacy.
* Participant's condition renders them unacceptable for further treatment in the judgment of the investigator.
Participants may continue on study protocol as long as their KS is continuing to respond or is clinically stable on study medication.
Patients may come off treatment for the following reasons:
* Disease progression.
* Need for more than 2 dose reductions for toxicity.
* Dose delay more than 28 days.
* Patient withdraws consent.
* Study termination by the Sponsor.
* Participants who are noncompliant with respect to taking drugs, keeping appointments, or having tests required for the evaluation of drug safety and efficacy.
* Participant's condition renders them unacceptable for further treatment in the judgment of the investigator.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: