NCT03890744

ModraDoc006/r in Patients With Breast Cancer

A Multicentre Phase IIa Study to Evaluate the Efficacy and Tolerability of ModraDoc006/r in Patients With Recurrent or Metastatic HER-2 Negative Breast Cancer, Suitable for Treatment With a Taxane

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Modra Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase IIa, multicentre, two-stage, single-arm, clinical study with the primary objective is to determine the efficacy of ModraDoc006 in combination with ritonavir (denoted ModraDoc006/r) in patients with recurrent or metastatic HER-2 negative breast cancer, as measured by RECIST v1.1 criteria of objective response rate (ORR). To this aim, a Simon two-stage minimax design will be used, in which 14 evaluable patients will be treated in the first stage (Stage A). If 0 or ≥ 2 objective responses at week 8 (with confirmation at week 12) are observed in Stage A, no further patients will be enrolled. If 1 objective response is observed, an additional 10 patients with recurrent or metastatic HER-2 negative breast cancer will be included in the second stage (Stage B). All patients will be treated with ModraDoc006/r, given as oral tablets twice daily once weekly (BIDW). Patients will be radiologically assessed at week 8 and 12 by CT scan (or MRI if CT is contraindicated), and may continue to receive study medication with ongoing radiological scans every 6 weeks until disease progression (according to RECIST v1.1), unacceptable toxicity, or discontinuation for any other reason. Furthermore, the safety and tolerability of ModraDoc006/r in the target population will be assessed. Additionally, as metastatic breast cancer may occur at older age, often coinciding with other non-malignant diseases and co-medications, this protocol investigates whether ModraDoc006/r can be applied safely in these (frail) patients.

Conditions

• Metastatic Breast Cancer
• Recurrent Breast Cancer

Interventions

Type	Name	Description
DRUG	ModraDoc006/r	Treatment with twice daily once weekly (BIDW) ModraDoc006 (oral docetaxel) 10mg tablets in combination with ritonavir 100mg tablets

Timeline

• Start date: 2019-01-30
• Primary completion: 2020-02-13
• Completion: 2020-11-09
• First posted: 2019-03-26
• Last updated: 2021-10-19

Locations

4 sites across 3 countries: Belgium, Denmark, Spain