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NCT00463814 Clinical Trial

AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in Patients With Advanced Solid Malignancies

Cancer Clinical Trial

Official title:
A Phase I, Open Label, Multi-centre Study to Assess the Safety, Tolerability and Pharmacokinetics of a Solid Oral Dosage Formulation (Capsule) of AZD6244 in Patients With Advanced Solid Malignancies

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00463814
Other study ID # D1532C00005
Secondary ID 2006-004497-26
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date March 8, 2007
Est. completion date December 31, 2024

Study information
Verified date April 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of the study is to assess the safety, tolerability and pharmacokinetics of a capsule of AZD6244 in patients with advanced solid malignancies.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 58
Est. completion date December 31, 2024
Est. primary completion date June 17, 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - cancer which is refractory to standard therapies - WHO performance status 0-2 - evidence of post-menopausal status or negative pregnancy test Exclusion Criteria: - Radiotherapy/chemotherapy within 21 days prior to entry - brain metastases/spinal cord compression unless stable off steroids/anticonvulsants - evidence of severe/uncontrolled systemic disease - participated in an investigational drug study within 30 days

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AZD6244
oral capsule

Locations
Country Name City State
Netherlands Research Site Nijmegen
Netherlands Research Site Utrecht
United Kingdom Research Site Sutton
United States Research Site Aurora Colorado

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Netherlands,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary To assess the pharmacokinetics of the solid dose form of AZD6244 each visit
Secondary To assess safety and tolerability of solid dose form of AZD6244 assessed at each visit
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