Tag Archive > clinical trials

Provenge Trial Ongoing & Recruiting At Eight US Centers

» 25 November 2009 » In Clinical trials, Dendreon, Prostate Cancer, Provenge, Vaccines » Comments Off

An open-label study of Sipuleucel-T (Provenge) is ongoing at 8 centers across the USA. This is a Phase 2 Study enrolling men with Metastatic Castrate Resistant Prostate Cancer (CRPC).

The aim of this study is to measure the immune responses to treatment with sipuleucel-T (Provenge). All participants will receive the drug.

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Provenge and Meta-Analysis — Compare Avandia

» 07 July 2007 » In Chemotherapy, Clinical trials, FDA, Prostate Cancer, Provenge » Comments Off

In submitting Provenge vaccine for the treatment of advanced prostate cancer for fast-tracked FDA approval despite aborting one clinical trial due to failure to meet the primary endpoint, Dendreon relied on meta-analysis of combined data from two parts of a phase III study, D9901. In fact, after the trials failed to meet their primary endpoint, time to progression, they were analysed twice over. Dr. Eric Small presented meta-analyses of impact on overall survival and prostate cancer specific survival and Dr. Daniel Petrylak presented a further analysis or suvival focused on a subset of patients who, when they progressed on Provenge, took Taxotere.

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