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Brief description/objective

Background:
Docetaxel, a semi-synthetic analogue of paclitaxel, is one of the most widely used human anti-cancer agents. Docetaxel and paclitaxel belong to a group of cytotoxic agents called tax-anes. Docetaxel has been marketed worldwide by Sanofi-Aventis under the trade name Taxotere® and its use is ap-proved for different types of solid tumors. The efficacy of docetaxel has been proven in two different phase 3 trials in metastatic castration resistant prostate cancer (mCRPC) and is a standard of care option for patients with prostate cancer. In Taxotere®, polysorbate 80 is used as surfactant. Fluid retention and hypersensitivity reactions are reported, and the patients are pre-treated
with corticosteroids, e.g. dexamethasone, to avoid or at least reduce the frequency and the severity of both hypersensitivity reactions and fluid retention.
Oasmia Pharmaceutical AB (Uppsala, Sweden) has developed a novel formulation of docetaxel (Docetaxel micellar) with N-(all-trans-retinoyl)-Lcysteic acid methyl ester sodium salt (XMeNa) as excipient, thus reducing adverse reactions caused by polysorbate 80. XMeNa forms micelles into which docetaxel can be incorporated thus increasing its aqueous solubility and keeping it dissolved.
Rational
Treatment with polysorbate 80-solved Docetaxel (Taxotere) is hampered by the requirement to co-administer steroid pre and post Taxotere infusion. Chronic (intermittent) steroids are hurt-ing bone health and have well known immunosuppressive ef-fects. Despite steroid premedication, polysorbate 80- solved Docetaxel (Taxotere) results in occasional infusion reactions due to the solvent polysorbate 80. The new micellar formulation of docetaxel is a promising alternative to polysorbate 80-solved Docetaxel (Taxotere) as it avoids the mandatory need for steroid administration pre and post infusion, and thus avoids immunosuppressive and bone-damaging effects.
Safety and pharmacokinetics (PK) of Docetaxel micellar have been assessed in 2 clinical studies, but only in breast cancer patients. This is the first clinical trial to assess the safety and tolerability of 3-weekly intravenous Docetaxel micellar infusions in patients with mCRPC.