Actively Recruiting
NCCH2006/MK010 Trial (FORTUNE Trial)
Led by National Cancer Center, Japan · Updated on 2025-10-03
75
Participants Needed
7
Research Sites
354 weeks
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
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).
CONDITIONS
Official Title
NCCH2006/MK010 Trial (FORTUNE Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic, unresectable, or recurrent solid tumor
- Agrees to provide an archival tumor sample, residual biopsy sample, or fresh tumor biopsy sample
- Ineffective or intolerant to initial treatment, or no standard treatment available
- Has FGFR gene alteration detected by NGS panel in specified groups (fusion, activating mutations, or gene amplification)
- For cholangiocarcinoma with prior selective FGFR inhibitor treatment and disease progression (Group D)
- Karnofsky Performance Status (KPS) ≥ 70 for primary CNS tumors; ECOG Performance Status 0-1 for others
- At least one measurable lesion by CT or MRI within 28 days before enrollment (with conditions for previously treated lesions)
- For primary CNS tumors: prior treatment received, measurable disease by MRI, neurologically stable for at least 7 days before enrollment
- Corrected calcium ≤ 10.1 mg/dL
- Phosphate ≤ 4.6 mg/dL
- Required treatment washout periods depending on prior therapy type
You will not qualify if you...
- Presence of brain, subdural, or leptomeningeal metastases
- Primary CNS tumor located in cerebellum, brainstem, spinal cord, pituitary gland, optic nerve, or olfactory nerve
- Positive for HIV antibody, HBs antigen, or HCV antibody (except HCV antibody positive with undetectable HCV-RNA)
- Positive for HBs antibody or HBc antibody with detectable HBV-DNA
- Child-Pugh score B or C
- Pericardial effusion, pleural effusion, or ascites requiring treatment
- Ocular diseases including Grade 2 or higher corneal disorders or active retinopathy
- Toxicity from prior treatments not recovered to Grade 1 or lower except alopecia, infertility, and certain lab results
- Prior selective FGFR inhibitor use in recurrent/metastatic setting except specific cholangiocarcinoma cases
- Need for drugs strongly inhibiting or inducing cytochrome P450 3A
- Presence of FGFR gatekeeper mutations (FGFR1 V561, FGFR2 V564/565, FGFR3 V555/557, FGFR4 V550)
- Coexisting driver gene abnormalities including KRAS, NRAS, EGFR, BRAF V600 mutations or ALK, ROS1, NTRK gene translocations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
M
Masamichi Takahashi, M.D., Ph.D.
CONTACT
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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