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

Phase 1

Completed

• Conditions: Melanoma; Malignant Melanoma
• Interventions: Drug: AZD6244

• Registration Number: NCT00710515
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-04
• Primary Completion: 2009-04
• Study Completion: 2010-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-12
• Last Update Posted: 2014-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	AZD6244	without food
1	AZD6244	with food

Primary Outcome Measures

Name	Time	Method
To assess whether food influences the rate and extent of AZD6244 absorption	Day 1 and Day 10

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of AZD6244 in patients with advanced solid malignancies	screening to 30 day post last dose
To determine the pharmacokinetics of both AZD6244 and N-desmethyl AZD6244 in the presence and absence of food	Day 1, 2, 3, 8, 9, and 10

Trial Locations

Locations (1)

Research Site; 🇬🇧 Oxford, United Kingdom