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A Study of Deforolimus (MK-8669) in Non-Small Cell Lung Cancer Patients with KRAS Mutations
[Protocol 09-047]
- Full Title :
- A RANDOMIZED DISCONTINUATION ON PHASE II TRIAL OF RIDAFOROLIMUS IN NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS WITH KRAS MUTATIONS
- Purpose :
The purpose of this study is to determine the safety and effectiveness of an investigational drug called deforolimus in patients with non-small cell lung cancer whose tumors contain a mutation in the KRAS gene.
Deforolimus is an inhibitor of mTOR, a protein found in normal and cancer cells. In
laboratory studies, deforolimus has been shown to slow the growth of some cancer cells with a KRAS mutation. KRAS is important for the growth of many lung cancers.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of stage IIIB or IV non-small cell lung cancer that contains a mutated form of the KRAS gene.
- Patients' disease must have progressed despite two prior chemotherapy regimens, at least one of which included a platinum-containing drug.
- At least 4 weeks must have passed since completion of prior chemotherapy and entry into the study.
- Patients may not have previously received rapamycin or rapamycin analogs, including deforolimus, everolimus, or temsirolimus.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Gregory Riely at 212-639-3042.
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