Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Melanoma

Malignant Melanoma

Treatments

Drug: AZD6244

Study type

Interventional

Funder types

Industry

Identifiers

NCT00710515

2007-004456-37 EudraCT Number

D1532C00020

Details and patient eligibility

About

The purpose of this study is to test if the levels of AZD6244 in blood are affected by taking food at the same time as the capsules compared to taking capsules on an empty stomach

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Able to eat a high fat breakfast within a 30-minute period
Advanced cancer which is refractory to standard therapies, for which no standard therapies exist
WHO or ECOG performance status 0-2 (those with performance status 2 must have been stable with no deterioration for over 2 weeks)

Exclusion criteria

Any radiotherapy or chemotherapy within 21 days prior to starting the study treatment (not including palliative radiotherapy at focal sites).
Any evidence of severe or uncontrolled systemic disease (eg., severe hepatic impairment, severe renal impairment, uncontrolled diabetes, acute uncontrolled infection) or current unstable or uncompensated respiratory or cardiac conditions or peripheral vascular disease including diabetic vasculopathy.
Refractory nausea and vomiting, chronic GI diseases (eg., inflammatory bowel disease) or significant bowel resection that would preclude adequate absorption.