drugset / Trial / NCT04238715

A Study of E7090 in Participants With Unresectable Advanced or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor (FGFR) 2 Gene Fusion

NCT04238715

Phase 2 Completed 63 enrolled Eisai Inc.
NaSingle-groupOpen-labelTreatment

Summary

The primary purpose of the study is to assess the objective response rate (ORR) of E7090 by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 based on independent imaging review (IIR) in participants with unresectable cholangiocarcinoma with FGFR2 gene fusion who failed gemcitabine-based combination chemotherapy.

Timeline

Start
2020-01-22
Primary completion
2025-11-03
Completion
2025-11-03

Drugs

EvaluationDrugModalityDoseRoute
Subject E7090 Small molecule 140 mg Oral

Indications