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Advanced or Recurrent Solid TumorsPhase 2NCT04962867

NCCH2006/MK010 Trial (FORTUNE Trial)

A Phase 2 study testing E7090 in people with Advanced or Recurrent Solid Tumors and FGFR Gene Alterations, run by National Cancer Center, Japan at 7 sites in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
E7090
Type of treatment
Pill or oral medicine
How many people
75 participants
Where
7 sitesJapan
Study dates
15 Jun 2021to 31 Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 22Show fewer
  • 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
  • Must be neurologically stable based on neurologic exam at least for the last 7 days prior to enrollment. (based on medical examination/interview)
  • Corrected calcium <= 10.1 mg/dL
  • Phosphate <= 4.6 mg/dL
  • Required treatment washout period, from the last day of prior treatment until enrollment of this trial, is as follows:
  • Antibody and other investigational drugs: >= 28 days
  • Prior chemotherapy (excluding small-molecule targeted therapy), surgical therapy, radiation therapy: >= 21 days (>= 90 days from the date of the last radiation therapy for primary CNS tumors)
  • Endocrine therapy, immunotherapy, small-molecule targeted therapy: >=14 days

Who cannot join

  • 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
Show all 16Show fewer
  • 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 whose toxicity of previous treatment has not recovered to Grade 1 or lower per Common Terminology Criteria for Adverse Events (CTCAE v5.0), except for alopecia, infertility, and the laboratory test results listed in the inclusion criteria
  • 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

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

+81-3-3542-2511

NCCH2006_office@ml.res.ncc.go.jp

7 sites in 1 country

Japan7 sites, 7 recruiting

  • Tohoku University Hospital

    Aoba-ku, Sendai, Miyagi, 980-8574

    Hisato Kawakami, M.D., Ph.D.

    Recruiting

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, Japan, 104-0045

    Kazuki Sudo, M.D., Ph.D.

    Recruiting

  • Kyushu University Hospital

    Higashi-Ku, Fukuoka, 812-8582

    Kenji Tsuchihashi, M.D., Ph.D.

    Recruiting

  • Hokkaido University Hospital

    Kita-Ku, Sapporo, Hokkaido, 060-8648

    Ichiro Kinoshita, M.D., Ph.D.

    Recruiting

  • Okayama University Hospital

    Okayama, 700-8558

    Eiki Ichihara, M.D., Ph.D., +81-86-223-7151, ichiha-e@md.okayama-u.ac.jp

    Recruiting

  • Kyoto University Hospital

    Sakyo-ku, Kyoto, 606-8507

    Junichi Matsubara, M.D., Ph.D.

    Recruiting

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

    Makoto Ueno, M.D., Ph.D., +81-45-520-2222, kccmakoto23u@gmail.com

    Recruiting

Other trials in Japan

About this study

Official title: 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)

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).

Being tested
E7090
Keywords
E7090, Solid tumor, Fibroblast Growth Factor Receptor (FGFR), FGFR inhibitor
Medical subject headings
Acrocephalosyndactylia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E7090Drug

    140 mg of E7090 is orally administered once daily.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline up to 3.5 years

Secondary outcomes (8)

  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 Response Assessment in Neuro-Oncology (RANO) criteria for primary Central Nervous System (CNS) tumor or RECIST v1.1 for other tumor type. ORR will be confirmed by local site investigator and/or independent blinded central review assessment.

    Measured: Baseline up to 3.5 years

  2. Progression-free survival (PFS)

    Progression-free survival (PFS) defined as the time from the date of enrollment to the date of the first documentation of objective progression of disease (PD), clinically diagnosed symptomatic deterioration, or death due to any cause in the absence of documented PD, whichever occurs first.

    Measured: Baseline up to 3.5 years

  3. Overall Survival (OS)

    Overall survival (OS) defined as the time from date of enrollment to date of death due to any cause.

    Measured: Baseline up to 3.5 years

  4. Disease control rate (DCR)

    Disease control rate (DCR) defined as the percentage of patients with a confirmed complete response (CR), partial response (PR) or stable disease (SD) as the best overall according to RECIST version 1.1.

    Measured: Baseline up to 3.5 years

  5. Adverse event (AE) rate

    Defined as the percentage of patients who experienced each adverse event. The severity of AEs were evaluated by the investigator according to Japan Clinical Oncology Group (JCOG) Japanese translation of the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0-JCOG).

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

  6. Adverse reaction (adverse drug reaction) rate

    Defined as the percentage of patients who experienced each adverse reaction (causally related to the protocol treatment). The severity of AEs were evaluated by the investigator according to Japan Clinical Oncology Group (JCOG) Japanese translation of the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0-JCOG).

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

  7. Duration of response (DOR)

    Duration of Response (DOR) defined as the time from the date of first documentation of CR or PR to the date of first documentation of disease progression or date of death from any cause, whichever occurs first.

    Measured: Baseline up to 3.5 years

  8. Time to response (TTR)

    Time to response (TTR) defined as the time from the date of first study dose to the date of first documentation of CR or PR according to RECIST version 1.1.

    Measured: Baseline up to 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2021
  2. Study start15 Jun 2021
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04962867
Sponsor's protocol ID
NCCH2006/MK010
Status last verified
Sep 2025
First submitted
12 Jul 2021
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35945547

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing E7090 in people with Advanced or Recurrent Solid Tumors and FGFR Gene Alterations, run by National Cancer Center, Japan at 7 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Masamichi Takahashi, M.D., Ph.D. (+81-3-3542-2511, NCCH2006_office@ml.res.ncc.go.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Baseline up to 3.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04962867, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.

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