Rigosertib for RDEB-SCC

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

April 12, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2026

Conditions
Epidermolysis Bullosa DystrophicaSquamous Cell Carcinoma
Interventions
DRUG

Rigosertib Oral Capsules / Rigosertib Intravenous

"Patients will take Rigosertib either as oral capsules or will get intravenous infusions depending on the needs of the patients.~Oral Capsules:~Patients will take oral Rigosertib continuously for a total of three weeks, every four week cycle (three weeks on, one week off drug) for up to 13 cycles. Patients will take 560 mg of oral Rigosertib (ie, 2 capsules of 280 mg) in the morning and in the afternoon, total of 1120mg/day.~Intravenous Infusions:~For IV treatment Rigosertib 1800 mg/24 hr is diluted in 0.9% sodium chloride for injection just prior to dosing and is administered as a 72-hr CIV infusion on days 1, 2, and 3 of a 2-week cycle for the first eight 2-week cycles, then on days 1, 2, and 3 of a 4-week cycle thereafter."

Trial Locations (1)

5020

RECRUITING

EB House Austria/Dept. of Dermatology University Hospital, Salzburg

All Listed Sponsors
lead

Prof. Johann Bauer

OTHER