-02341066 and PF-00299804 for Advanced Non-Small Cell Lung Cancer
- PF-02341066 and PF-00299804 are drugs that specifically target certain proteins that may be more active in cancer cells than normal cells, in particular in non-small cell lung cancer. Both drugs seem to be able to stop the growth of or kill cancer cells. Researchers want to combine them to see if they are a safe and effective treatment for advanced non-small cell lung cancer.
- To test the safety and effectiveness of PF-02341066 and PF-00299804 for advanced non-small cell lung cancer.
- Individuals at least 18 years of age with advanced non-small cell lung cancer that has not responded to standard treatments.
- Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, and imaging studies. Heart and lung function tests and an eye exam may also be given.
- The first cycle of treatment will be 28 days. Every cycle after the first will be 21 days. Participants may have up to 17 cycles of treatment.
- Participants will take both study drugs as tablets. Twelve hours after the first dose, participants will take only the PF-02341066. This dose schedule will remain the same throughout the study.
- Participants will be monitored with frequent blood and urine tests and imaging studies. Tumor biopsies will be taken as needed. Those in the study will keep a diary to record any symptoms or side effects of taking the study drugs.
- After 17 cycles of treatment, or after stopping the study drugs early for any other reason, participants will have a final followup visit.
Carcinoma, Non-Small Cell Lung
Carcinoma, Squamous Cell
Carcinoma, Large Cell
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Open-Label, Dose Escalation Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of Combined Oral C-Met/ALK Inhibitor (PF-02341066) and Pan-Her Inhibitor (PF-0299804) in Patients With Advanced Non-Small Cell Lung Cancer|
- Overall safety profile of combined PF-0234 1066 plus PF-00299804 including adverse events.
- PK parameters of PF-02341066 and PF-00299804. Clinical activity of said combined drugs including objective response. Tumor and blood biomarkers that are potentially predictive of drug activity or modulated following drug exposure.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Arun Rajan, M.D.||National Cancer Institute (NCI)|