CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 75 target
Drug / intervention
E7090drug
Likely dose
E7090 140 mgfrom record
Key inclusion· 8
  • ✓Histologically or cytologically confirmed metastatic, unresectable, or recurrent solid tumor with tumor sample provision
  • ✓Ineffective to, intolerant to, or no standard treatment available for initial treatment
  • ✓FGFR gene alteration detected by NGS: FGFR1-3 fusion (Group A), specific activating mutations (Group B/E), or other activating mutations/amplifications (Group C)
  • ✓Karnofsky Performance Status ≥70 for primary CNS tumors; ECOG 0-1 for non-primary CNS tumors
Key exclusion· 12
  • ✕Brain, subdural, or leptomeningeal metastases
  • ✕Primary CNS tumor in cerebellum, brainstem, spinal cord, pituitary gland, optic nerve, or olfactory nerve
  • ✕Positive for HIV antibody, HBs antigen, or HCV antibody (exceptions: HCV antibody positive with undetectable RNA)
  • ✕HBs antigen negative but HBs antibody or HBc antibody positive AND HBV-DNA positive (exception: HBV-DNA below detection)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04962867
NCT04962867Phase 2RecruitingOn TrackUpdated 8mo ago
Long Recruiting
CompareCT.gov

Multicenter Investigator-initiated Phase II Trial of E7090 in Patients With Advanced or Recurrent Solid Tumor With Fibroblast Growth Factor Receptor (FGFR) Gene Alteration (FORTUNE Trial)

National Cancer Center, Japan·interventional·Posted Jul 15, 2021·Updated Oct 3, 2025

In Brief

A Phase 2 clinical trial evaluating E7090 for Advanced or Recurrent Solid Tumors and FGFR Gene Alterations. Currently recruiting, targeting 75 participants across 7 sites.

Detailed Summary

This is a single-arm, open-label, multicenter, investigator-initiated Phase 2 trial to evaluate the efficacy and safety of E7090 in patients with advanced or recurrent solid tumors harboring FGFR genetic alterations (including fusion, mutation, amplification).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced or Recurrent Solid Tumors, FGFR Gene Alterations
CountriesJapan
CollaboratorsEisai Co., Ltd.

Timeline

Phase 2Recruiting
2022202320242025202620272028
First PostedJul 15, 2021
Enrollment StartJun 15, 2021
Primary CompletionMar 31, 2028
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 5.0 years agoPrimary completion in 1.7 years

Interventions

E7090drug

140 mg of E7090 is orally administered once daily.