Trial intelligence / Profile preview

Debio 1347 plus Fulvestrant in FGFR-amplified Breast Cancer

NCT03344536Phase 2

Key facts

Status
Completed
Start
Nov 2017
Primary completion
Aug 2021
Countries
1
Sponsor
Memorial Sloan Kettering Cancer Center
Modality
Small Molecules
Conditions
breast cancer
01

Overview

Phase 2, open-label, single-arm trial of zoligratinib in breast cancer, sponsored by Memorial Sloan Kettering Cancer Center. Primary endpoints: Dose Limiting Toxicity at 1 year and Best Overall Response at 1 year. Started Nov 2017; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • fulvestrant and Debio 1347

    Combination of zoligratinib and fulvestrant

03

Who it enrols

Patients with metastatic HR+/HER2- breast cancer with FGFR amplification.

04

Endpoints

Primary

  • Dose Limiting Toxicity

  • Best Overall Response

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