January 15, 2008 |
March 6, 2009 |
December 2007 |
Safety and tolerability of twice daily oral doses of AZD6244 when administered in combination with standard doses of selected chemotherapies. |
Same as current |
Complete list of historical versions of study NCT00600496 on ClinicalTrials.gov Archive Site |
- PK of AZD6244 and selected chemotherapies.
- Define highest tolerated dose of AZD6244 when in combination with selected chemotherapies.
- Tumor response.
- Identify factors which may influence the sensitivity to AZD6244 or agents used in combination
|
Same as current |
|
A Phase I, Open-Label, Multi-Center Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6244 (ARRY-142886) |
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. |
|
Phase I |
Interventional |
Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study |
- Breast Cancer
- Breast Neoplasms
- Colon Cancer
- Colonic Cancer
- Colon Neoplasms
- Lung Cancer
- Melanoma
- Kidney Cancer
|
- Drug: AZD6244
- Drug: Dacarbazine
- Drug: Erlotinib
- Drug: Docetaxel
- Drug: Temsirolimus
|
- Experimental: AZD6244 + docetaxel
- Experimental: AZD6244 + Dacarbazine
- Experimental: AZD6244 + Erlotinib
- Experimental: AZD6244 + Temsirolimus
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|
|
Recruiting |
80 |
May 2009 |
May 2009 (final data collection date for primary outcome measure) |
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
|
Both |
18 Years and older |
No |
|
United States |
|
|
NCT00600496 |
Rajesh Chopra, MD - Medical Science Director, AstraZeneca |
|
AstraZeneca |
|
Principal Investigator: |
Patricia LoRusso, DO |
Karmanos Cancer Institute |
|
Principal Investigator: |
Roger Cohen, MD |
Fox Chase Cancer Center |
|
Principal Investigator: |
Jeffrey Infante, MD |
Sarah Cannon Research Institute |
|
Principal Investigator: |
Kevin Kim, MD |
M.D. Anderson Cancer Center |
|
|
AstraZeneca |
March 2009 |