Netherlands-based oncology drugs developer Modra Pharmaceuticals has started patient enrolment in a Phase II clinical trial of modraDoc006/r to treat patients with metastatic castration-resistant prostate cancer.
ModraDoc006/r is an oral formulation of docetaxel (ModraDoc006) given along with boosting-agent ritonavir to improve bioavailability of the chemotherapy.
Ritonavir is an inhibitor of the drug efflux transporter protein P-glycoprotein (P-gp) and the liver enzyme cytochrome P450 3A4 (CYP3A4).
The systemic bioavailability of docetaxel is enhanced by ritonavir through inhibition of metabolism.
The multi-centre Phase II trial is designed to evaluate the safety, feasibility and pharmacokinetic profile of the formulation in 20 chemotherapy naïve patients indicated with intravenous (IV) docetaxel.
Modra Pharmaceuticals CEO Eric van der Putten said: “Modra Pharmaceuticals aims to apply its oral formulation technology in oncology, 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.
“With the promising results we have seen in our Phase I studies and given the nature of our approach, we are highly confident that we can advance this compound quickly with the aim to initiate a pivotal programme by early 2018.”
The dose-escalation trial will further establish a feasible dosing regimen of the formulation and the maximum tolerated dose that is safe to be given in a bi-daily weekly schedule without intervals.
The trial’s secondary outcome is the measure of pharmacodynamics of modraDoc006/r.
The firm aims to offer clinicians with multiple options for prescribing combinatorial treatments of cancer regimens.