ModraDoc006/r in Patients With Breast Cancer

NCT03890744 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-10-19

No results posted yet for this study

Summary

This is a multicenter phase IIa study to evaluate the efficacy and tolerability of ModraDoc006 in combination with ritonavir (denoted ModraDoc006/r) in patients with recurrent or metastatic HER-2 negative breast cancer, that are suitable for treatment with a taxane as 1st-3rd line of therapy.

Conditions

Interventions

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

  • Marianne Keessen · Modra Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2020-02-13
Completion
2020-11-09

Countries

  • Belgium
  • Denmark
  • Spain

Study Locations

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Entities

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 NCT03890744 on ClinicalTrials.gov