Malignant Melanoma, Melanoma
Conditions
Keywords
Melanoma, Phase I, AZD6244
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
Interventions
DRUGAZD6244
75mg
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess whether food influences the rate and extent of AZD6244 absorption | Day 1 and Day 10 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Netherlands, United Kingdom
Outcome results
None listed