On February 23, 2022 Oasmia Pharmaceutical AB (Oasmia), an oncology-focused specialty pharmaceutical company, reported that the first patient has now fully completed the study in the Investigator-Initiated Phase 1b trial of Docetaxel micellar for advanced prostate cancer (trial SAKK 67/20 of the Swiss Group for Clinical Cancer Research SAKK) (Press release, Oasmia, FEB 23, 2022, View Source [SID1234608863]). Furthermore, the first of three dosing groups in the trial has been successfully recruited and the first patient has started in the second dose group.
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Francois Martelet, MD, Chief Oasmia Officer, Oasmia, commented: "We are grateful for the significant effort of the Swiss Group for Clinical Cancer Research (SAKK), our investigators and clinics have made in progressing the study so far. SAKK has informed us that it is well-positioned to complete recruitment this year and secure data crucial for the continued development of Docetaxel micellar."
Oasmia’s Docetaxel micellar is a solvent-free formulation of docetaxel developed to avoid the need for the solubility enhancers in solvent-based docetaxel, and the mandatory high-dose steroid premedication, while providing an effective treatment option. Prostate cancer is a significant and increasingly prevalent health problem worldwide and is the leading cause of male cancer deaths.
The SAKK 67/20 trial (NCT04629781) is an open-label, multicenter, single-stage Phase 1b trial at major hospitals in Switzerland, recruiting 18 chemotherapy-naïve patients with metastatic castration resistant prostate cancer (mCRPC) with adequate bone marrow, liver, and renal function. The primary objective of this trial is to determine the maximum tolerated dose of Docetaxel micellar in patients with mCRPC and the secondary objectives are to evaluate safety, assess the preliminary anti-tumor activity, and to characterize the pharmacokinetics in this population.