Phase I and pharmacokinetic study of ABI-007, albumin-bound paclitaxel, administered every 3 weeks in Japanese patients with solid tumors.

Japanese Journal of Clinical Oncology
Kazuhiko YamadaT Tamura

Abstract

ABI-007 is a novel Cremophor EL-free nanoparticle albumin-bound paclitaxel. This Phase I study was designed to evaluate tolerability and determine recommended dose for Japanese patients when ABI-007 was administered in every-3-week schedule. Pharmacokinetics of paclitaxel was also assessed. Patients with advanced solid tumors refractory to standard therapy received a 30 min intravenous infusion of ABI-007 every 3 weeks without pre-medications at 200, 260 or 300 mg/m(2), respectively. Tolerability and recommended dose were determined by the standard '3 + 3' rule. No dose-limiting toxicity was observed, despite the dose escalation. In another cohort, 260 mg/m(2) was re-evaluated and resulted in no dose-limiting toxicity. Grade 3 or 4 neutropenia was reported for the majority of patients (n = 8) but no incidence of febrile neutropenia. Non-hematological toxicities were generally mild except for Grade 3 sensory neuropathy (n = 3). Pharmacokinetic study demonstrated the area under the curve of paclitaxel increased with increasing the dosage, and comparable pharmacokinetic parameters to the western population. Partial response was observed in three non-small cell lung cancer patients. Two of whom had received docetaxel-containing che...Continue Reading

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Citations

Jul 28, 2011·OncoTargets and Therapy·Yutaka YamamotoHirotaka Iwase
Jul 23, 2014·Critical Reviews in Oncology/hematology·A ViúdezM Hidalgo
Jul 23, 2013·Critical Reviews in Oncology/hematology·Raphaelle FanciullinoGérard Milano
Oct 11, 2011·Advanced Drug Delivery Reviews·Sandrine DufortJean-Luc Coll
May 18, 2016·Gastric Cancer : Official Journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association·Norisuke NakayamaWasaburo Koizumi
Apr 29, 2015·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Hidenori MizugakiTomohide Tamura
Nov 7, 2015·Drugs·Hannah A Blair, Emma D Deeks
Jun 15, 2017·Clinical Pharmacokinetics·Tore B StageDeanna L Kroetz
Jul 20, 2016·International Cancer Conference Journal·Emika IchiokaHisato Hara
Mar 5, 2017·Advanced Drug Delivery Reviews·Alexandros Marios SofiasChristine Allen

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