Status:
COMPLETED
Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies
Lead Sponsor:
AstraZeneca
Conditions:
Melanoma
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00710515
Start Date
July 1 2008
End Date
June 1 2010
Last Update
August 13 2014
Active Locations (6)
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1
Research Site
Amsterdam, Netherlands
2
Research Site
Maastricht, Netherlands
3
Research Site
Glasgow, United Kingdom
4
Research Site
Headington, United Kingdom