A Study of Selumetinib in Patients With Kaposi's Sarcoma

Conditions

• AIDS-related Kaposi's Sarcoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Selumetinib — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jun 15, 2012

Status verified

Feb 2019

Primary completion

Sep 30, 2015

Completion

Dec 20, 2017

Study Design

Enrollment

19 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Selumetinib treatment
  Phase I is a dose-finding study to discover the maximum tolerated dose of selumetinib in combination with HAART. Phase II will consider the efficacy of selumetinib for treating Kaposi's sarcoma at the recommended phase II dose discovered in phase I.

Primary Outcome Measure

Toxicity of Selumetinib in Combination with HAART [ Time Frame: 3.5 years ]