AB Science initiates Phase III trial of masitinib in mCRPC, but …

A French company called AB Science has initiated a Phase III clinical trial of masitinib (yet another tyrosine kinase inhibitor) in the treatment of metastatic, castration-resistant prostate cancer (mCRPC).

According to a recent media release from the company, the trial is an international, multi-center, randomized, double-blind, placebo-controlled, Phase III study designed to compare the efficacy and safety of masitinib + docetaxel to a placebo + docetaxel as first-line treatment for men with mCRPC. (We assume that all patients would also be receiving prednisone or prednisolone along with the docetaxel, although the media release does not state this explicitly.) The primary study endpoint is overall survival.

As yet, there is no information available on the ClinicalTrials.gov web site about whether the proposed trial will be available to US-based patients with mCRPC. Masitinib is already being and/or has already been tested in Phase III trials for several other possible cancer indications.

Whether or not this new trial does become available in the USA, The “New” Prostate Cancer InfoLink would suggest that patients might want to think carefully before deciding to participate in this study, and discuss it with their doctors. Masitinib has twice failed to gain approval from European regulatory agencies on the basis of earlier Phase III trials (for the treatment of non-resectable, locally advanced or metastatic pancreatic cancer and for the treatment of gastrointestinal tumors or GIST). The new Phase III trial in mCRPC is based on data from an earlier Phase II study in which just 34 patients with mCRPC, all of whom had already progressed on treatment with docetaxel alone were apparently treated with masitinib + docetaxel.

To date, no tyrosine kinase inhibitor has ever demonstrated significant clinical value in the treatment of mCRPC, and one has to say that it looks increasingly likely that tyrosine kinase inhibition may offer little or no significant clinical benefit for the majority of patients with mCRPC. We would be happy to be proven wrong about this … but at the same time one has to wonder whether the available data really support the development and implementation of this new Phase III trial of masitinib.

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