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ModraDoc006/r in Metastatic Castration-resistant Prostate Cancer

NCT03136640 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-10-19

No results posted yet for this study

Summary

This is a safety, feasibility and pharmacokinetic study to confirm that the recommended safe dose and schedule of ModraDoc006/r (oral docetaxel with ritonavir) as determined in a previous phase I study is also safe and feasible in the target population of patients with CRPC.

Conditions

  • Castration-resistant Prostate Cancer

Interventions

DRUG

ModraDoc006/r

Treatment with weekly ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Modra Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Andre Bergman, MD, PhD · The Netherlands Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-26
Primary Completion
2019-09-05
Completion
2019-09-05

Countries

  • Netherlands

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 NCT03136640 on ClinicalTrials.gov