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Absorption and Excretion of Oral Docetaxel

NCT05242926 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-02-16

No results posted yet for this study

Summary

This is an open-label, phase I study to investigate the influence of the bi-daily weekly dosing of ModraDoc006/ritonavir on the absorption and excretion of docetaxel in patients with advanced solid tumours.

The pharmacokinetics, absorption and excretion of docetaxel will be investigated during the study.

Patients will receive 30 mg in the morning / 20 mg in the afternoon ModraDoc006 with BID 100 mg ritonavir in a fasted condition (i.e. at least 1 hour before or 2 hours after any food assumption), followed by collection of plasma, faeces and urine samples.

Conditions

  • Solid Tumor, Adult

Interventions

DRUG

ModraDoc006/r

One time bi-daily dosing (30/20 mg) of ModraDoc006 in combination with ritonavir 100 mg tablets

Sponsors & Collaborators

  • Modra Pharmaceuticals

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-31
Primary Completion
2018-04-30
Completion
2018-06-30

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 NCT05242926 on ClinicalTrials.gov