Nab-pacliatxel Plus Gemcitabine in Korean Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Status:
Unknown status
Trial end date:
2021-06-01
Target enrollment:
Participant gender:
Summary
Nab-paclitaxel (interchangeable with ABRAXANE and ABI-007) is a unique protein formulation of
a noncrystalline, amorphous form of paclitaxel in an insoluble particle state. Nab-paclitaxel
was designed to improve the chemotherapeutic effects of paclitaxel by exploiting endogenous
transport pathways to deliver higher doses of paclitaxel to the tumor and to reduce the
solvent-related hypersensitivity and other toxicities associated with Taxol® (paclitaxel)
injections, the solvent Cremophor EL, and ethanol vehicle. Nab-paclitaxel provides more rapid
tissue distribution and increased tumor accumulation compared to cremophor-EL paclitaxel.
Mechanistically, albumin receptor-mediated transport across the endothelium, binding to
interstitial proteins, and macropinocytic or receptor-mediated uptake into tumor cells as
well as sequestration of paclitaxel by cremophor-EL may contribute to the observed
differences. Furthermore, nab-paclitaxel synergizes with gemcitabine in preclinical models.
The Cremophor EL-free medium enables nab-paclitaxel to be given at a higher dose and in a
shorter duration without the need for premedication to prevent solvent-related
hypersensitivity reactions. As of March 2014, nab-paclitaxel is approved under the trade name
of ABRAXANE in over 45 countries/regions, including the US, Canada, India, European
Union/European Economic Area, South Korea, China, Australia, Bhutan, United Arab Emirates,
Nepal, New Zealand, Japan, Russia, Sri Lanka, Argentina, Hong Kong, and Lebanon for the
treatment of patients with metastatic breast cancer. ABRAXANE is also approved for the
first-line treatment of locally advanced or metastatic non small cell lung cancer (NSCLC) in
the US, Japan, Argentina, Australia, and New Zealand, for treatment of advanced gastric
cancer in Japan, and for first-line treatment of metastatic adenocarcinoma of the pancreas in
the US, EU/EEA, Australia, New Zealand and Argentina.