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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710515
• Other study ID #: D1532C00020
• Secondary ID: 2007-004456-37 E
• Status: Completed
• Phase: Phase 1
• First received: July 2, 2008
• Last updated: August 12, 2014
• Start date: July 2008
• Est. completion date: June 2010

Study information

• Verified date: August 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medicines Evaluation Board (MEB)United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• AZD6244
75mg

Locations

Country	Name	City	State
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Maastricht
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Headington
United Kingdom	Research Site	London
United Kingdom	Research Site	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess whether food influences the rate and extent of AZD6244 absorption		Day 1 and Day 10	Yes
Secondary	To determine the pharmacokinetics of both AZD6244 and N-desmethyl AZD6244 in the presence and absence of food		Day 1, 2, 3, 8, 9, and 10	Yes
Secondary	To assess the safety and tolerability of AZD6244 in patients with advanced solid malignancies		screening to 30 day post last dose	Yes