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Oral Docetaxel in Patients With Normal or Impaired Liver Function

NCT05084456 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-10-19

No results posted yet for this study

Summary

This is an open label, single centre pharmacological and safety study to define the safety and pharmacokinetics of ModraDoc006/r in a weekly dosing schedule in patients with impaired liver function who might have benefit from a weekly docetaxel regime. The safety of ModraDoc006 in combination with ritonavir for the patients with mild and moderate impaired liver function will be evaluated with a dose escalation design.

Conditions

  • Solid Tumor, Adult
  • Impaired Liver Function

Interventions

DRUG

ModraDoc006/r

Treatment with weekly ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets in fed or fasting condition

Sponsors & Collaborators

  • Modra Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Serena Marchetti, MD/PhD · The Netherlands Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2020-02-29
Completion
2020-04-30

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 NCT05084456 on ClinicalTrials.gov