Oasmia Pharmaceutical has announced that the first patient has been dosed in a Phase 1b clinical trial of its Docetaxel micellar in patients with advanced prostate cancer.
The trial is being conducted by the Swiss Group for Clinical Cancer Research (SAKK).
“We are pleased to be partnering with SAKK on this trial which we believe is an important step towards evaluating whether Docetaxel micellar can be a treatment option for patients with advanced prostate cancer, without the mandatory steroid use that is necessary with existing, solvent-based docetaxel formulations,” says Heidi B. Ramstad, Chief Medical Officer of Oasmia.
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, states the company in a press release.
The SAKK 67/20 trial
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.
The Swiss Group for Clinical Cancer Research (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 Heidi B. Ramstad, Chief Medical Officer of Oasmia (left)