Phase III Trial Comparing Orteronel (TAK-700) Plus Prednisone Against Placebo Plus Prednisone Fails

Reporting both negative clinical trial results is as important as reporting positive results. However, pharmaceutical companies often bury negative results. Fortunately (actually unfortunately because there were negative results) a Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in men with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or after docetaxel-based therapy failed to meet its endpoints, or has failed. The study included 1,099 men with advanced prostate cancer who were randomly assigned in a 2:1 schedule to receive TAK-700. The primary end point was overall survival (OS). Key secondary end points [...]

The Well Reviewed Guide to Advanced Prostate Cancer (A Survivor Perspective) Has Been Updated and is Now Available for a free Download

Somehow I have been negligent and not let people know that I have written and posted a major update of my “Guide to Advanced Prostate Cancer.” As in the past, it is available as a free download from the Malecare web site. Helping me to update the book was prostate cancer survivor Craig Pynn and my own caretaker, Wendy Lebowitz. Anyone reading the first edition will be surprised when you see how many changes and updates this edition has included. It now has a very extensive conversation about living in the world as a cancer survivor as well as more [...]

TAK-700 Fails to Offer A Survival Extension

Much of my reporting about ASCO 2014 has included only positive studies, but there is always a share of studies and trials that do not prove to be of a direct positive  value to men with Advanced Prostate Cancer.  Today’s report includes one of these negative reports.  Remember, a negative report is as valuable as a positive one as we can now know about a treatment, procedure etc. that does warrant additional expenditures of time or money. De Wit et al. reported the results of a second, large, phase III clinical trial of orteronel (aka -TAK-700) + prednisone in the [...]

Takeda Un-blinds & Halts the Phase 3 Study of Orteronel in Men with mCRPC That Progressed Post-Chemotherapy

A press release made yesterday brought some bad news to the advanced prostate cancer community. Takeda Pharmaceutical Company Limited (“Takeda”) announced that it has un-blinded and stopped the ELM-PC 5 Phase 3 study (C21005) of orteronel plus prednisone compared to placebo plus prednisone in patients with metastatic, castration- resistant prostate cancer (mCRPC) that had progressed during or following chemotherapy based on the recommendation of the Independent Data Monitoring Committee (IDMC). Many of us know ELM-PC5 as TAK-700. The trial was halted after an interim analysis indicated that orteronel plus prednisone would likely not meet the primary endpoint of improved overall [...]