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.

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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.

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"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."

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.

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“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.