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Pain palliation as an oncology label indication:...
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Pain palliation as an oncology label indication: Lessons learned in custirsen phase III development.

Abstract

222 Background: Durable pain palliation (dPP) in metastatic castrate-resistant prostate cancer (mCRPC) is a measure of clinical benefit suitable for a label indication. A randomized, double-blind, placebo-controlled, phase III study developed with FDA under a Special Protocol Assessment (SPA) compared custirsen/taxane (cust/tax) to placebo/taxane (plac/tax) as second-line chemotherapy for patients (pts) with mCRPC with disease …

Authors

Beer TM; Hotte SJ; De Bono JS; Beuzeboc P; Gabrail NY; Cain D; Jacobs C; Fizazi K

Volume

32

Pagination

pp. 222-222

Publisher

American Society of Clinical Oncology (ASCO)

Publication Date

February 1, 2014

DOI

10.1200/jco.2014.32.4_suppl.222

Conference proceedings

Journal of Clinical Oncology

Issue

4_suppl

ISSN

0732-183X