Authors
Daniel D Von Hoff, Monica M Mita, Ramesh K Ramanathan, Glen J Weiss, Alain C Mita, Patricia M LoRusso, Howard A Burris III, Lowell L Hart, Susan C Low, Donald M Parsons, Stephen E Zale, Jason M Summa, Hagop Youssoufian, Jasgit C Sachdev
Publication date
2016/7/1
Journal
Clinical Cancer Research
Volume
22
Issue
13
Pages
3157-3163
Publisher
American Association for Cancer Research
Description
Purpose: First-in-human phase I trial to determine the safety, pharmacokinetics, and antitumor activity of BIND-014, a novel, tumor prostate-specific membrane antigen (PSMA)–targeted nanoparticle, containing docetaxel.
Experimental Design: Patients with advanced solid tumors received BIND-014 every three weeks (n = 28) or weekly (n = 27), with dose levels ranging from 3.5 to 75 mg/m2 and 15 to 45 mg/m2, respectively.
Results: BIND-014 was generally well tolerated, with no unexpected toxicities. The most common drug-related toxicities (>20% of patients) on either schedule included neutropenia, fatigue, anemia, alopecia, and diarrhea. BIND-014 demonstrated a dose-linear pharmacokinetic profile, distinct from docetaxel, with prolonged persistence of docetaxel-encapsulated circulating nanoparticles. Of the 52 patients evaluable for response, one had a complete response …
Scholar articles
DD Von Hoff, MM Mita, RK Ramanathan, GJ Weiss… - Clinical Cancer Research, 2016