Back to resultsStudy to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies
Primary Purpose
Melanoma, Malignant Melanoma
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AZD6244
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Phase I, AZD6244
Eligibility Criteria
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.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
with food
without food
Outcomes
Primary Outcome Measures
To assess whether food influences the rate and extent of AZD6244 absorption
Secondary Outcome Measures
To determine the pharmacokinetics of both AZD6244 and N-desmethyl AZD6244 in the presence and absence of food
To assess the safety and tolerability of AZD6244 in patients with advanced solid malignancies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00710515
Brief Title
Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Malignant Melanoma
Keywords
Melanoma, Phase I, AZD6244
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
with food
Arm Title
2
Arm Type
Experimental
Arm Description
without food
Intervention Type
Drug
Intervention Name(s)
AZD6244
Intervention Description
75mg
Primary Outcome Measure Information:
Title
To assess whether food influences the rate and extent of AZD6244 absorption
Time Frame
Day 1 and Day 10
Secondary Outcome Measure Information:
Title
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
Title
To assess the safety and tolerability of AZD6244 in patients with advanced solid malignancies
Time Frame
screening to 30 day post last dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh Chopra
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jan Schellens
Organizational Affiliation
Maastricht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Amsterdam
Country
Netherlands
Facility Name
Research Site
City
Maastricht
Country
Netherlands
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Headington
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Oxford
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies
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