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A Phase Ib/IIa Study of AV-951 in Patients with Advanced Non-Small Cell Lung Cancer
[Protocol 08-144]
- Full Title :
- A PHASE 1B/2A OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND ACTIVITY OF ONCE DAILY ORAL ADMINISTRATION OF AV-951 IN SUBJECTS WITH NON-SMALL CELL LUNG CANCER
- Purpose :
The purpose of this study is to evaluate the safety and effectiveness of an investigational drug called AV-951 in patients with advanced non-small cell lung cancer (NSCLC) that cannot be treated with standard therapies. AV-951 is designed to fight cancer by cutting off the blood supply to tumors. Without blood, the cancer cannot get the nutrients it needs to grow.
Researchers will first determine the highest dose of AV-951 that can be given safely. They will then examine the activity of this drug against advanced NSCLC.
- 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 NSCLC that has recurred or progressed despite standard therapy or for which no standard therapy exists and which cannot be surgically removed.
- For the phase Ib portion of the study, at least 4 weeks must have passed since prior VEGF-targeted therapies and entry into the study. Patients in the phase IIa portion may not have had prior VEGF-directed therapy.
- Patients may have had up to 3 prior regimens of chemotherapy. At least 4 weeks must have passed since completion of prior chemotherapy, immunotherapy, or biologic therapy and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be age 18 or older.
For more information and to inquire about eligibility for this study, please contact Dr. Naiyer Rizvi at 212-639-3204.
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