ModraDoc006/r in Patients With Breast Cancer

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03890744
Study type	Interventional
Source	Modra Pharmaceuticals
Contact
Status	Completed
Phase	Phase 2
Start date	January 30, 2019
Completion date	November 9, 2020

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