NCCH2006/MK010 Trial (FORTUNE Trial)

NCT04962867 | Recruiting Phase 2

• 1 other identifier: NCCH2006/MK010
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 7

Brief 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).

Conditions

Advanced or Recurrent Solid Tumors; FGFR Gene Alterations

Keywords

E7090; Solid tumor; Fibroblast Growth Factor Receptor (FGFR); FGFR inhibitor

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Overall response rate (ORR) defined as the combined incidence of complete response (CR) and PR, confirmed no less than 4 weeks after the criteria for response are first met, based on RECIST v1.1. ORR will be confirmed by independent blinded central review assessment.

  Baseline up to 3.5 years

Secondary Outcomes (8)

• Objective response rate (ORR)

  Baseline up to 3.5 years

• Progression-free survival (PFS)

  Baseline up to 3.5 years

• Overall Survival (OS)

  Baseline up to 3.5 years

• Disease control rate (DCR)

  Baseline up to 3.5 years

• Adverse event (AE) rate

  From the first dose of the investigational product until 30 days after the last dose of study drugs

Interventions

E7090 DRUG

140 mg of E7090 is orally administered once daily.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with histologically or cytologically confirmed metastatic, unresectable, or recurrent solid tumor who agree to provide an archival tumor sample, a residual biopsy sample, or a fresh tumor biopsy sample
• Ineffective to or intolerant to initial treatment, or for which standard treatment is no longer available
• Participants with an FGFR gene alteration detected by NGS panel, who fall under one of the categories of groups A to C and E defined as below
• Group A: FGFR1-3 fusion
• Group B and E: FGFR1-3 specific activating mutations as below;
• FGFR1: P150S, T340M, R445W, N546K, K656E
• FGFR2: C62Y, A67V, N82K, D101Y, E160K, E163K, M186T, R203H, R210Q, Q212K, R251Q, S252W, P253R, P253L, A264T, W290C, K310R, Y328N, G364E, Y375C, C382R, A389T, V392A, R399Q, H416R, I422V, H544Q, N549H, N549K, N549D, N549S, L560F, K659E, K659N, R664W, E718K, S791T
• FGFR3: G380E, G380R, A391E, K650T, K650E, K650Q, K650N
• Group C: FGFR1-3 activating mutation not applicable to group B, or FGFR1, 2 gene amplification
• For Group D, participants with cholangiocarcinoma who have previously received a selective FGFR inhibitor other than E7090 and have demonstrated progressive disease or resistance
• Karnofsky Performance Status (KPS) \>= 70 for patients with primary CNS tumors. Performance Status (ECOG) 0-1 for patients with non-primary CNS tumors
• For patients with non-primary CNS tumors, they have at least 1 lesion of \>= 10 millimeter (mm) in the longest diameter for a non-lymph node or \>= 15 mm in the short-axis diameter for a lymph node that is considered as serially measurable according to RECIST v1.1 using computerized tomography or magnetic resonance imaging (CT or MRI) within 28 days of enrollment. However, lesions that have received local treatment such as external-beam radiation therapy (EBRT) or radiofrequency ablation (RFA) must have progressed after these local treatment to count as measurable lesion
• Participants with primary CNS tumors must meet all of the following criteria:
• Have received prior treatment including radiation and/or chemotherapy, as recommended or appropriate for the CNS tumor type
• Have \>= 1 site of bi-dimensionally measurable disease (confirmed by magnetic resonance imaging (MRI) and evaluable by RANO criteria), with the size of at least one of the measurable lesions \>= 1 cm in each dimension and noted on more than one imaging slice. Imaging study performed within 28 days before enrollment

You may not qualify if:

• Participants with brain, subdural or leptomeningeal metastases
• Participants with primary CNS tumor located in either cerebellum, brainstem, spinal cord, pituitary gland, optic nerve or olfactory nerve
• Positive for either human immunodeficiency virus (HIV) antibody, HBs antigen, or HCV antibody (patients with positive HCV antibody but no detectable HCV-RNA are not excluded)
• Negative for HBs antigen, but positive for HBs antibody or HBc antibody, and also positive for HBV-DNA quantification (not excluded if HBV-DNA is below detection sensitivity)
• Child-Pugh score B or C
• Participants with pericardial effusion, pleural effusion, or ascites requiring treatment
• Have any of the following ocular diseases
• Grade 2 or higher corneal disorders
• Active retinopathy (e.g., age-related macular degeneration, central serous chorioretinal disease, retinal tear)
• Participants who received a prior selective FGFR inhibitor in the recurrent/metastatic disease setting; except for patients with cholangiocarcinoma harboring FGFR2 fusion (Group D). Note that prior use of a multi-kinase inhibitor which includes anti-FGFR activity is acceptable after review by the lead investigator
• Participants who need the use of drugs that strongly inhibits or induces the metabolizing enzyme cytochrome P450 (CYP) 3A
• The presence of FGFR gatekeeper mutations as follows: FGFR1 V561, FGFR2 V564/565, FGFR3 V555/557, FGFR4 V550
• The presence of any of the following coexisting driver gene abnormalities:
• Genetic mutations (excluding VUS): KRAS, NRAS, EGFR, or BRAF V600
• Gene translocations: ALK, ROS1, or NTRK

Sponsors & Collaborators

• National Cancer Center, Japan: lead
• Eisai Co., Ltd.: collaborator

Study Sites (7)

National Cancer Center Hospital

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

RECRUITING

Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

Tohoku University Hospital

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

RECRUITING

Kyushu University Hospital

Higashi-Ku, Fukuoka, 812-8582, Japan

RECRUITING

Hokkaido University Hospital

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

RECRUITING

Okayama University Hospital

Okayama, 700-8558, Japan

RECRUITING

Kyoto University Hospital

Sakyo-ku, Kyoto, 606-8507, Japan

RECRUITING

Related Publications (1)

• Chiba Y, Sudo K, Kojima Y, Okuma H, Kohsaka S, Machida R, Ichimura M, Anjo K, Kurishita K, Okita N, Nakamura K, Kinoshita I, Takahashi M, Matsubara J, Kusaba H, Yonemori K, Takahashi M. 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. BMC Cancer. 2022 Aug 9;22(1):869. doi: 10.1186/s12885-022-09949-8.

  PMID: 35945547 DERIVED

MeSH Terms

Conditions

Acrocephalosyndactylia

Condition Hierarchy (Ancestors)

Craniosynostoses; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Syndactyly; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

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

CONTACT

+81-3-3542-2511; NCCH2006_office@ml.res.ncc.go.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 15, 2021
• Study Start: June 15, 2021
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (7)