Trials / Completed
CompletedNCT04238715
A Study of E7090 in Participants With Unresectable Advanced or Metastatic Cholangiocarcinoma With Fibroblast Growth Factor Receptor (FGFR) 2 Gene Fusion
A Multicenter, Open-Label, Phase 2 Trial of E7090 in Subjects With Unresectable Advanced or Metastatic Cholangiocarcinoma With FGFR 2 Gene Fusion
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- Eisai Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E7090 | E7090 tablets orally. |
Timeline
- Start date
- 2020-01-22
- Primary completion
- 2025-11-03
- Completion
- 2025-11-03
- First posted
- 2020-01-23
- Last updated
- 2026-03-02
Locations
56 sites across 2 countries: China, Japan
Source: ClinicalTrials.gov record NCT04238715. Inclusion in this directory is not an endorsement.