Modra Pharmaceuticals Starts Phase 2 Trial of Oral Docetaxel in Metastatic Prostate Cancer

Modra Pharmaceuticals Starts Phase 2 Trial of Oral Docetaxel in Metastatic Prostate Cancer
Modra Pharmaceuticals has enrolled its first patient in a Phase 2 clinical trial (NCT03136640) of  ModraDoc006/r as a treatment for metastatic castration-resistant prostate cancer — an advanced and often fatal form of the disease ModraDoc006/r is a tablet formulation of docetaxel. Doctors administer it with the chemotherapy ritonavir to boost ritonavir's bioavailablity, or amount that the body can absorb. “Modra Pharmaceuticals aims to apply its oral formulation technology in oncology [cancer treatment], with an initial focus on taxane-based chemotherapy, to offer patients a better quality of life through a simpler and more effective route of administration,” Eric van der Putten, Modra's CEO, said in a press release. The company has been working to develop more convenient, yet equally efficient, ways to administer chemotherapy. ModraDoc006/r is its lead candidate. It performed well in Phase 1 clinical trials of patients with solid tumors. The Phase 2 trial aims to recruit 20 patients who have yet to be treated with chemotherapy. To be eligible, men should have metastatic castration-resistant prostate cancer, a condition that is usually treated with intravenous docetaxel. To establish the maximum tolerated dose of the treatment — the main goal of the trial —  participants will receive increasing doses of ModraDoc006/r. Six patients will be treated and evaluated for toxic effects before the next group receives dosing. Researchers will also analyze ModraDoc006/r's
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