NCT04028388

ModraDoc006/r vs Docetaxel IV in Metastatic Prostate Cancer

A Multicentre Phase 2b Trial to Evaluate the Efficacy and Tolerability of ModraDoc006/r in Subjects With Metastatic Castration Resistant Prostate Cancer (mCRPC), Suitable for Treatment With a Taxane

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Modra Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter phase 2b study to evaluate the efficacy and tolerability of ModraDoc006 in combination with ritonavir (denoted ModraDoc006/r) in patients with metastatic castration-resistant prostate cancer, suitable for treatment with a taxane.

Detailed description

This is an open label 1:1 randomized Phase 2b trial to determine the efficacy and tolerability of oral ModraDoc006/r versus i.v. docetaxel in mCRPC subjects. Cohort 1 will receive i.v. docetaxel at 75 mg/m2 every 3 weeks (Q3W). Cohort 2 will receive 30 mg ModraDoc006 in combination with 200 mg ritonavir in the morning and 20 mg ModraDoc006 in combination with 100 mg ritonavir in the evening (7-12 hours after the morning dose), on Day 1, 8 and 15 of a 21-day cycle (BIDW). All patients will also receive 5 mg oral prednisone twice daily. Treatment in both cohorts will continue until disease progression, unacceptable toxicity, or discontinuation for any other reason. The end of the trial is defined as the time point when all subjects have discontinued trial treatment and have been given follow-up for safety measurements according to the trial assessment schedule.

Conditions

• Prostate Cancer Metastatic
• Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel in Parenteral Dosage Form	Treatment with IV docetaxel at 75 mg/m2 given as a one-hour infusion on day 1 every 21 days plus 5 mg oral prednisone twice daily
DRUG	ModraDoc006/r	Treatment with twice daily once weekly (BIDW) ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets

Timeline

• Start date: 2019-07-17
• Primary completion: 2021-11-29
• Completion: 2021-11-29
• First posted: 2019-07-22
• Last updated: 2024-04-17
• Results posted: 2024-04-17

Locations

28 sites across 6 countries: United States, Czechia, Germany, Hungary, Poland, Russia

Regulatory

• FDA-regulated drug study