AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in Patients With Advanced Solid Malignancies
This trial is active, not recruiting.
|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|
|Aurora, CO||Research Site||no longer recruiting|
|Nijmegen, Netherlands||Research Site||no longer recruiting|
|Utrecht, Netherlands||Research Site||no longer recruiting|
|Sutton, United Kingdom||Research Site||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
To assess the pharmacokinetics of the solid dose form of AZD6244
time frame: each visit
To assess safety and tolerability of solid dose form of AZD6244
time frame: assessed at each visit
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
|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|
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