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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma, Malignant Melanoma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Day 1 and Day 10

Safety Issue:

Yes

Principal Investigator

Rajesh Chopra

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Netherlands: Medicines Evaluation Board (MEB)

Study ID:

D1532C00020

NCT ID:

NCT00710515

Start Date:

July 2008

Completion Date:

June 2010

Related Keywords:

  • Melanoma
  • Malignant Melanoma
  • Melanoma
  • Phase I
  • AZD6244
  • Melanoma

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