An Open-label, Phase I/II Trial of ABI-007 (A Cremophor EL-Free, Protein Stabilized, Nanoparticle, Paclitaxel) Administered Weekly in Chemotherapy Naive Patients With Advanced Non-Small Cell Lung Cancer
ABI-007, a unique protein formulation of paclitaxel, has been developed to reduce the
toxicities associated with Taxol and Cremophor EL/ethanol vehicle while maintaining or
improving the chemotherapeutic effect of the drug.
The activity of ABI-007 in other malignancies is not yet well established. This open-label
Phase I/II study is being conducted to define the maximum tolerated dose (MTD) and
dose-limiting toxicities (DLT) of ABI-007, and evaluate the safety and antitumor activity of
ABI-007 in patients with advanced Stage IV non-small cell lung cancer (NSCLC).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|