A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Lung Cancer, Colorectal Cancer, Skin Cancer, Cancer, Kidney Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 127 |
| Updated: | 3/29/2019 |
| Start Date: | December 14, 2007 |
| End Date: | December 31, 2019 |
A Phase I, Open-Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886) When Given in Combination With Standard Doses of Selected Chemotherapies to Patients With Advanced Solid Tumors
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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