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

NCT00710515 | Completed Phase 1

• 2 other identifiers: D1532C000202007-004456-37 EudraCT Number
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 6

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

Conditions

Melanoma; Malignant Melanoma

Keywords

Melanoma; Phase I; AZD6244

Outcome Measures

Primary Outcomes (1)

• To assess whether food influences the rate and extent of AZD6244 absorption

  Day 1 and Day 10

Secondary Outcomes (2)

• 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

• To assess the safety and tolerability of AZD6244 in patients with advanced solid malignancies

  screening to 30 day post last dose

Study Arms (2)

1

EXPERIMENTAL

with food

Drug: AZD6244

2

EXPERIMENTAL

without food

Drug: AZD6244

Interventions

AZD6244 DRUG

75mg

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research Site

Amsterdam, Netherlands

Location

Research Site

Maastricht, Netherlands

Location

Research Site

Glasgow, United Kingdom

Location

Research Site

Headington, United Kingdom

Location

Research Site

London, United Kingdom

Location

Research Site

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Melanoma

Interventions

AZD 6244

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rajesh Chopra

  AstraZeneca

  STUDY DIRECTOR

• Jan Schellens

  Maastricht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: July 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: June 1, 2010
• Last Updated: August 13, 2014

Record last verified: 2014-08

Locations

GB (4); NL (2)