Oasmia Pharmaceutical has announced that Swissmedic and Swissethics approval has been received to initiate a Phase 1b clinical trial with the Swiss Group for Clinical Cancer Research (SAKK) of Oasmia’s Docetaxel micellar in patients with advanced prostate cancer.
Trial initiation is expected to commence in the first half of 2021, states the company in a press release.
About the trial
The SAKK 67/20 trial 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. Using a standard Phase I trial design, the primary objective of this study is to determine the maximum tolerated dose of Docetaxel micellar in patients with mCRPC. The secondary objectives are to evaluate the safety of Docetaxel micellar, to assess the preliminary anti-tumor activity, and to characterize the pharmacokinetics of Docetaxel micellar in this population. The treatment will be a 21-day cycle of one of three dose levels of Docetaxel micellar until progression or occurrence of unacceptable toxicity or withdrawal, for a maximum of 10 cycles.
SAKK is a non-profit organization, which has been conducting clinical trials in oncology since 1965. Its primary objective is to research new cancer therapies, to develop existing treatments further and to improve the chances of a cure for patients with cancer.
Photo of Francois Martelet, CEO, Oasmia Pharmaceuticals