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

Status

Completed

Conditions

Intervention / Treatment

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

  • Netherlands
      • Amsterdam, Netherlands
        • Research Site
      • Maastricht, Netherlands
        • Research Site
  • United Kingdom
      • Glasgow, United Kingdom
        • Research Site
      • Headington, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • Oxford, United Kingdom
        • Research Site

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
Drug: AZD6244
75mg
Experimental: 2
without food
Drug: AZD6244
75mg

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
Day 1 and Day 10

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
Day 1, 2, 3, 8, 9, and 10
To assess the safety and tolerability of AZD6244 in patients with advanced solid malignancies
Time Frame: screening to 30 day post last dose
screening to 30 day post last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

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

Keywords

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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