This trial is active, not recruiting.

Conditions tumor, cancer
Treatment azd6244
Phase phase 1
Target MEK
Sponsor AstraZeneca
Start date March 2007
End date June 2008
Trial size 64 participants
Trial identifier NCT00463814, D1532C00005


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
azd6244 ARRY-142886
oral capsule

Primary Outcomes

To assess the pharmacokinetics of the solid dose form of AZD6244
time frame: each visit

Secondary Outcomes

To assess safety and tolerability of solid dose form of AZD6244
time frame: assessed at each visit

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.