A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886)
Completed · Phase 1
Conditions studied: Breast Cancer, Breast Neoplasms, Colon Cancer, Colonic Cancer, Colon Neoplasms, Lung Cancer, Melanoma, Kidney Cancer
In brief
This study is being conducted to determine if a combination of AZD6244 given orally twice a day with standard doses of selected chemotherapies will be safe and tolerable for cancer patients with advanced solid tumors. The highest tolerated dose of AZD6244 in combination with selected chemotherapies will be evaluated. The study will also investigate how AZD6244 in combination with standard chemotherapies are absorbed, distributed and excreted by the body as well as the length of time that the drugs remain in the body. Initial and periodic assessments will establish patient response to the combination therapies
Key facts
- Study ID
- NCT00600496
- Run by
- AstraZeneca
- People needed
- 140
- Starts
- 2007-12-14
- Expected to finish
- 2025-12-18
- Last updated by the study team
- 2026-05-27
Who can join
Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients will have measurable and/or non-measurable disease, lacking curative options for whom the selected chemotherapy agents represent the standard of care
- WHO performance status 0-1
- Patients must be able to swallow AZD6244 capsules
You may not qualify if…
- Prior treatment with a MEK inhibitor
- Participation in a clinical study during the last 30 days or have not recovered from side effects of an investigational study drug
- Brain metastases or spinal cord compression unless treated and stable (for at least 1 month) off steroids
Where it is running
- Research Site — Detroit, Michigan, United States
- Research Site — Philadelphia, Pennsylvania, United States
- Research Site — Nashville, Tennessee, United States
- Research Site — Houston, Texas, United States
Full record on ClinicalTrials.gov
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