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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00710515
First Posted: July 4, 2008
Last Update Posted: August 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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

Condition Intervention Phase
Melanoma Malignant Melanoma Drug: AZD6244 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess whether food influences the rate and extent of AZD6244 absorption [ Time Frame: Day 1 and Day 10 ]

Secondary Outcome Measures:
  • 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 ]
  • To assess the safety and tolerability of AZD6244 in patients with advanced solid malignancies [ Time Frame: screening to 30 day post last dose ]

Enrollment: 30
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
with food
Drug: AZD6244
75mg
Experimental: 2
without food
Drug: AZD6244
75mg

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710515


Locations
Netherlands
Research Site
Amsterdam, Netherlands
Research Site
Maastricht, Netherlands
United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
Headington, United Kingdom
Research Site
London, United Kingdom
Research Site
Oxford, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Rajesh Chopra AstraZeneca
Principal Investigator: Jan Schellens Maastricht
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00710515     History of Changes
Other Study ID Numbers: D1532C00020
2007-004456-37 EudraCT Number
First Submitted: July 2, 2008
First Posted: July 4, 2008
Last Update Posted: August 13, 2014
Last Verified: August 2014

Keywords provided by AstraZeneca:
Melanoma
Phase I
AZD6244

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas