- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00710515
Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies
August 12, 2014 updated by: AstraZeneca
A Phase I, Open-Label Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Amsterdam, Netherlands
- Research Site
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Maastricht, Netherlands
- Research Site
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Glasgow, United Kingdom
- Research Site
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Headington, United Kingdom
- Research Site
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London, United Kingdom
- Research Site
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Oxford, United Kingdom
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
with food
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75mg
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Experimental: 2
without food
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75mg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess whether food influences the rate and extent of AZD6244 absorption
Time Frame: Day 1 and Day 10
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Day 1 and Day 10
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the pharmacokinetics of both AZD6244 and N-desmethyl AZD6244 in the presence and absence of food
Time Frame: Day 1, 2, 3, 8, 9, and 10
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Day 1, 2, 3, 8, 9, and 10
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To assess the safety and tolerability of AZD6244 in patients with advanced solid malignancies
Time Frame: screening to 30 day post last dose
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screening to 30 day post last dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Rajesh Chopra, AstraZeneca
- Principal Investigator: Jan Schellens, Maastricht
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
July 2, 2008
First Submitted That Met QC Criteria
July 3, 2008
First Posted (Estimate)
July 4, 2008
Study Record Updates
Last Update Posted (Estimate)
August 13, 2014
Last Update Submitted That Met QC Criteria
August 12, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1532C00020
- 2007-004456-37 EudraCT Number
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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