24.12.2012 Views

Download the ESMO 2012 Abstract Book - Oxford Journals

Download the ESMO 2012 Abstract Book - Oxford Journals

Download the ESMO 2012 Abstract Book - Oxford Journals

SHOW MORE
SHOW LESS

Create successful ePaper yourself

Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.

or hypercalcemia at screening; prior chemo<strong>the</strong>rapy, biologic, or experimental <strong>the</strong>rapy<br />

for mCRPC; or radio<strong>the</strong>rapy to bone lesions and/or orthopedic surgery for<br />

pathologic fractures. A total of 216 pts receiving standard of care (luteinizing<br />

hormone-releasing hormone [LHRH] antagonists) and bisphosphonate <strong>the</strong>rapy will<br />

be randomized 1:1:1 to receive in a blinded manner placebo, 1500 mg or 750 mg<br />

EMD 525797 (all 1-h intravenous [IV] infusions) on day 1 of every 3-week cycle<br />

until radiographic disease progression (PD). At progression, <strong>the</strong>rapy will be<br />

unblinded and pts in <strong>the</strong> placebo group who show asymptomatic or mildly<br />

symptomatic radiographic confirmed PD can receive open-label <strong>the</strong>rapy with 1500<br />

mg EMD 525797. The primary endpoint is composite progression-free survival,<br />

defined as <strong>the</strong> time (months) from randomization date to first documented sign of<br />

Annals of Oncology<br />

objective radiographic PD or death from any cause. Secondary endpoints include<br />

efficacy (e.g. overall survival and time to progression), safety, <strong>the</strong> pharmacokinetic<br />

profile of EMD 525797, and <strong>the</strong> exploration of a relationship between <strong>the</strong> number of<br />

circulating tumor cells and clinical outcomes. As of April <strong>2012</strong>, 106 pts have entered<br />

<strong>the</strong> trial.<br />

Disclosure: K. Miller: Membership on an advisory board for Merck KGaA,<br />

Darmstadt, Germany, G. Mordenti: Employee of Merck KGaA, Darmstadt,<br />

Germany, H. Lannert: Employee of Merck KGaA, Darmstadt, Germany. All o<strong>the</strong>r<br />

authors have declared no conflicts of interest.<br />

ix318 | <strong>Abstract</strong>s Volume 23 | Supplement 9 | September <strong>2012</strong>

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!