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MobyInvestor

08/01/10 5:58 PM

#54691 RE: mojojojo #54663

Are you referring to these "signal seeking" trials?

Only some of them:

Official Title: A Phase II Safety and Efficacy Study of Bavituximab Plus Paclitaxel and Carboplatin in Patients With Locally Advanced or Metastatic Breast Cancer
Primary Outcome Measures:

* The primary objective of this study is to determine the overall response rate (CR+PR) [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
http://www.clinicaltrials.gov/ct2/show/NCT00669565?term=bavituximab&phase=1&rank=4

Official Title: A Randomized, Open-Label, Phase 2 Trial of Paclitaxel/Carboplatin With or Without Bavituximab in Patients With Previously Untreated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
Primary Outcome Measures:

* Objective Response Rate [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
http://www.clinicaltrials.gov/ct2/show/NCT01160601?term=bavituximab&phase=1&rank=2

Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Bavituximab Plus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer
Primary Outcome Measures:

* Objective Response Rate [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
http://www.clinicaltrials.gov/ct2/show/NCT01138163?term=bavituximab&phase=1&rank=5

That's odd. In 3 of the 5 phase II Bavi AC trials safety was never mentioned as a primary or secondary outcome measure.

And, 2 of those trials are of the gold-standard variety...

Regards,

moby