A Study of Selumetinib in Patients With Kaposi's Sarcoma

Summary

Cancer is a leading cause of death in individuals living with human immunodeficiency virus (HIV), and Kaposi's sarcoma (KS) remains the commonest HIV-associated cancer. KS is caused when individuals become infected with both HIV and another virus, Human herpesvirus-8 (HHV-8). Laboratory studies have shown that HHV-8 can stimulate biological pathways within KS lesions which promotes their growth. Selumetinib targets these pathways and may therefore be a useful new therapy for KS. Phase I of this trial aims to identify the best dose for the use of selumetinib and investigate the effects of selumetinib treatment on the anti-viral treatment HIV patients receive to control HIV infection. Phase II of this trial will investigate how well selumetinib works as a treatment for KS at the best dose determined in phase I.

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.

Sponsors & Collaborators

• University of Birmingham

  collaborator OTHER

• AstraZeneca

  collaborator INDUSTRY

• Thermo Fisher Scientific, Inc

  collaborator INDUSTRY

• Cancer Research UK

  collaborator OTHER

• University of Sheffield

  collaborator OTHER

• Sheffield Teaching Hospitals NHS Foundation Trust

  lead OTHER

Principal Investigators

• Mark Bower, Professor · Chelsea & Westminster Hospital, London

• Diana Ritchie, Dr. · Beatson West of Scotland Cancer Centre, Glasgow

• Sarah Westwell, Dr. · Royal Sussex County Hospital, Brighton

• Michael Leahy, Dr · The Christie Hospital, Manchester

• Robin Young, Dr · West Park Hospital, Sheffield

• Grant Stewart, Dr · Royal Free Hospital NHS Foundation Trust

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-15

Primary Completion

2015-09-30

Completion

2017-12-20

Countries

• United Kingdom

Study Locations