Actively Recruiting

Phase 2
Age: 20Years +
All Genders
ID04962867

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)

Led by National Cancer Center, Japan · Updated on 2025-10-03

75

Participants Needed

7

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National Cancer Center, Japan

Lead Sponsor

E

Eisai Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the drug E7090 in a Phase 2 clinical trial involving patients with advanced or recurrent solid tumors that have specific FGFR gene alterations. This study aims to assess the effectiveness and safety of E7090 in this group of patients who have tumors with FGFR fusions, mutations, or amplifications. The trial is being conducted at multiple centers and is sponsored by the National Cancer Center in Japan. Participants receive 140 mg of E7090 orally once daily. This is an open-label, single-arm study, meaning all participants receive the same treatment without a comparison group. The study monitors participants over a period of up to 3.5 years to evaluate how their tumors respond to the treatment and to track any side effects or adverse reactions. Throughout the trial, participants undergo regular assessments including tumor measurements using CT or MRI scans, neurological exams for certain tumor types, and laboratory tests for calcium and phosphate levels. Researchers will measure outcomes such as the objective response rate, progression-free survival, overall survival, disease control rate, duration and time to response, as well as adverse event rates. The trial includes a treatment and follow-up period lasting up to 3.5 years to fully assess the drug's impact and safety.

CONDITIONS

Brief Title

NCCH2006/MK010 Trial (FORTUNE Trial)

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants with confirmed metastatic, unresectable, or recurrent solid tumor who agree to provide tumor samples
  • Ineffective or intolerant to initial treatment, or no standard treatment available
  • Presence of FGFR gene alteration detected by NGS panel, including specific fusions, mutations, or amplifications
  • For cholangiocarcinoma patients previously treated with selective FGFR inhibitors and showing progression
  • Karnofsky Performance Status \u2265 70 for CNS tumors; ECOG 0-1 for non-CNS tumors
  • At least one measurable lesion \u2265 10 mm (non-lymph node) or \u2265 15 mm (lymph node) for non-primary CNS tumors
  • For primary CNS tumors: prior treatment, measurable disease by MRI, and neurological stability
  • Corrected calcium \u2264 10.1 mg/dL
  • Phosphate \u2264 4.6 mg/dL
  • Required washout periods from prior treatments: \u2265 28 days for antibodies/ investigational drugs, \u2265 21 days for chemotherapy/radiation, \u2265 14 days for endocrine/immunotherapy/small-molecule therapies
Not Eligible

You will not qualify if you...

  • Brain, subdural, or leptomeningeal metastases
  • Primary CNS tumor in cerebellum, brainstem, spinal cord, pituitary, optic nerve, or olfactory nerve
  • Positive for HIV antibody, HBs antigen, or HCV antibody (unless HCV-RNA undetectable)
  • Positive HBV-DNA quantification with negative HBs antigen
  • Child-Pugh score B or C liver disease
  • Pericardial, pleural effusion, or ascites requiring treatment
  • Certain ocular diseases including grade 2 or higher corneal disorders and active retinopathy
  • Unresolved toxicity from previous treatments above grade 1 except alopecia, infertility, and certain labs
  • Prior selective FGFR inhibitor use except for specific cholangiocarcinoma group
  • Need for drugs that strongly affect cytochrome P450 3A enzyme
  • Presence of FGFR gatekeeper mutations
  • Presence of other driver gene abnormalities like KRAS, NRAS, EGFR, BRAF V600 mutations or ALK, ROS1, NTRK translocations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - From first dose until disease progression or discontinuation

Participants receive 140 mg of E7090 orally once daily as the investigational drug to treat advanced or recurrent solid tumors with FGFR gene alterations.

Trial Site Locations

Total: 7 locations

1

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan, Japan, 104-0045

Actively Recruiting

2

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan, 241-8515

Actively Recruiting

3

Tohoku University Hospital

Aoba-ku, Sendai, Miyagi, Japan, 980-8574

Actively Recruiting

4

Kyushu University Hospital

Higashi-Ku, Fukuoka, Japan, 812-8582

Actively Recruiting

5

Hokkaido University Hospital

Kita-Ku, Sapporo, Hokkaido, Japan, 060-8648

Actively Recruiting

6

Okayama University Hospital

Okayama, Japan, 700-8558

Actively Recruiting

7

Kyoto University Hospital

Sakyo-ku, Kyoto, Japan, 606-8507

Actively Recruiting

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Research Team

M

Masamichi Takahashi, M.D., Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

A multicenter investigator-initiated Phase 2 trial of E7090 in patients with advanced or recurrent solid tumor with fibroblast growth factor receptor (FGFR) gene alteration: FORTUNE trial.

Yohei Chiba, Kazuki Sudo, Yuki Kojima...

https://pubmed.ncbi.nlm.nih.gov/35945547