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ModraDoc006/r vs Docetaxel IV in Metastatic Prostate Cancer

NCT04028388 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2024-04-17

Study results available
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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.

Conditions

  • Prostate Cancer Metastatic
  • Castration-resistant Prostate Cancer

Interventions

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

Sponsors & Collaborators

  • Modra Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • M Keessen, MSc, MBA · Modra Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-17
Primary Completion
2021-11-29
Completion
2021-11-29
FDA Drug
Yes

Countries

  • United States
  • Czechia
  • Germany
  • Hungary
  • Poland
  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04028388 on ClinicalTrials.gov