Open-label Dose Escalation Phase 1b Trial of a New Micellar Docetaxel Compound in Patients With mCRPC

Summary

Treatment with polysorbate 80-solved Docetaxel (Taxotere®) is hampered by the requirement to co-administer steroids. Chronic (intermittent) steroids are negatively impacting bone health and have well known immunosuppressive effects. Despite steroid premedication, polysorbate 80-solved Docetaxel (Taxotere®) results in occasional infusion reactions due to the solvent polysorbate 80. Docetaxel micellar 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. There is an unmet medical need to develop steroid-free taxane regimens for patients with advanced cancer to avoid the need for steroid administration pre and post infusion (as outlined above). The unique Docetaxel micellar formulation suggests an improved safety profile compared to polysorbate 80-solved Docetaxel (Taxotere®).

Timeline

Start

2021-05-28

Primary completion

2024-01-29

Completion

2024-01-29

Outcome

Outcome not reported

Stopped: “SAKK decided to premature terminate this trial as additional follow-up visits do not further contribute to the efficacy data. This decision does not adversely impact the patients.”

Drugs

Indications