A Study of Selumetinib in Patients With Kaposi's Sarcoma

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

June 15, 2012

Primary Completion Date

September 30, 2015

Study Completion Date

December 20, 2017

Conditions
AIDS-related Kaposi's Sarcoma
Interventions
DRUG

Selumetinib

"The treatment schedule requires selumetinib to be taken either once daily at the same time each day or twice daily approximately 12 hours apart. Selumetinib should be taken with water at least 2 hours after a meal and 1 hour before the next meal. Selumetinib capsules will be administered in a continuous 21 day cycle (6 cycles), unless disease progression occurs.~For phase I there were 4 potential dosing levels:~Level -1 - 50mg once daily (od) (50mg daily total)~Level 1 (starting dose level for phase I) - 50mg bi-daily (bd) (100mg daily total)~Level 2 - 75mg bd (150mg daily total)~Level 3 - 100mg bd (200mg daily total)~Phase I has been completed and identified 75mg bd as the recommended phase II dose.~Phase II has begun and is utilising a dose of 75mg bd of selumetinib."

Trial Locations (6)

BN2 5BE

Brighton and Sussex University Hospitals, Brighton

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

NW3 2QG

Royal Free Hospital, London

SW10 9NH

Chelsea & Westminster Hospital, London

M20 4BX

The Christie Hospital, Manchester

S10 2SJ

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

Sponsors
All Listed Sponsors
collaborator

University of Birmingham

OTHER

collaborator

AstraZeneca

INDUSTRY

collaborator

Thermo Fisher Scientific, Inc

INDUSTRY

collaborator

Cancer Research UK

OTHER

collaborator

University of Sheffield

OTHER

lead

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER