Open-label Dose Escalation Phase 1b Trial of a New Micellar Docetaxel Compound in Patients With mCRPC
Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
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®).