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NCCH2006/MK010 Trial (FORTUNE Trial)

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ClinicalTrials.gov Identifier: NCT04962867
Recruitment Status : Recruiting
First Posted : July 15, 2021
Last Update Posted : August 30, 2021
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
National Cancer Center, Japan

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).

Condition or disease Intervention/treatment Phase
Advanced or Recurrent Solid Tumors FGFR Gene Alterations Drug: E7090 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 15, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: E7090
    140 mg of E7090 is orally administered once daily.


Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Baseline up to 3.5 years ]
    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.


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Baseline up to 3.5 years ]
    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.

  2. Progression-free survival (PFS) [ Time Frame: Baseline up to 3.5 years ]
    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.

  3. Overall Survival (OS) [ Time Frame: Baseline up to 3.5 years ]
    Overall survival (OS) defined as the time from date of enrollment to date of death due to any cause.

  4. Disease control rate (DCR) [ Time Frame: Baseline up to 3.5 years ]
    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.

  5. Adverse event (AE) rate [ Time Frame: From the first dose of the investigational product until 30 days after the last dose of study drugs ]
    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).

  6. Adverse reaction (adverse drug reaction) rate [ Time Frame: From the first dose of the investigational product until 30 days after the last dose of study drugs ]
    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).

  7. Duration of response (DOR) [ Time Frame: Baseline up to 3.5 years ]
    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.

  8. Time to response (TTR) [ Time Frame: Baseline up to 3.5 years ]
    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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Ineffective to or intolerant to initial treatment, or for which standard treatment is no longer available
  3. Participants with an FGFR gene alteration detected by NGS panel, who fall under one of the categories of groups A to C defined as below

    Group A: FGFR1-3 fusion

    Group B: FGFR1-3 specific activating mutations

    Group C: FGFR1-3 activating mutation not applicable to group B, or FGFR1, 2 gene amplification

  4. For Group D, participants with cholangiocarcinoma who have previously received a selective FGFR inhibitor other than E7090 and have demonstrated progressive disease or resistance
  5. Karnofsky Performance Status (KPS) >= 70 for patients with primary CNS tumors. Performance Status (ECOG) 0-1 for patients with non-primary CNS tumors
  6. 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
  7. Participants with primary CNS tumors must meet all of the following criteria:

    1. Have received prior treatment including radiation and/or chemotherapy, as recommended or appropriate for the CNS tumor type
    2. 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
    3. Must be neurologically stable based on neurologic exam at least for the last 7 days prior to enrollment. (based on medical examination/interview)
  8. Corrected calcium <= 10.1 mg/dL
  9. Phosphate <= 4.6 mg/dL
  10. Required treatment washout period, from the last day of prior treatment until enrollment of this trial, is as follows:

    1. Antibody and other investigational drugs: >= 28 days
    2. 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)
    3. Endocrine therapy, immunotherapy, small-molecule targeted therapy: >=14 days

Exclusion Criteria:

  1. Participants with brain, subdural or leptomeningeal metastases
  2. Participants with primary CNS tumor located in either cerebellum, brainstem, spinal cord, pituitary gland, optic nerve or olfactory nerve
  3. 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)
  4. 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)
  5. Child-Pugh score B or C
  6. Participants with pericardial effusion, pleural effusion, or ascites requiring treatment
  7. Have any of the following ocular diseases

    1. Grade 2 or higher corneal disorders
    2. Active retinopathy (e.g., age-related macular degeneration, central serous chorioretinal disease, retinal tear)
  8. 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
  9. 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
  10. Participants who need the use of drugs that strongly inhibits or induces the metabolizing enzyme cytochrome P450 (CYP) 3A
  11. The presence of FGFR gatekeeper mutations as follows: FGFR1 V561, FGFR2 V564/565, FGFR3 V555/557, FGFR4 V550
  12. The presence of any of the following coexisting driver gene abnormalities:

    1. Genetic mutations (excluding VUS): KRAS, NRAS, EGFR, or BRAF V600
    2. Gene translocations: ALK, ROS1, or NTRK

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04962867


Contacts
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Contact: Masamichi Takahashi, M.D., Ph.D. +81-3-3542-2511 NCCH2006_office@ml.res.ncc.go.jp

Locations
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Japan
Tohoku University Hospital Recruiting
Aoba-ku, Sendai, Miyagi, Japan, 980-8574
Contact: Masanobu Takahashi, M.D., Ph.D.         
National Cancer Center Hospital Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Contact: Masamichi Takahashi, M.D., Ph.D.         
Kyushu University Hospital Recruiting
Higashi-Ku, Fukuoka, Japan, 812-8582
Contact: Hitoshi Kusaba, M.D., Ph.D.         
Hokkaido University Hospital Recruiting
Kita-Ku, Sapporo, Hokkaido, Japan, 060-8648
Contact: Ichiro Kinoshita, M.D., Ph.D.         
Kyoto University Hospital Recruiting
Sakyo-ku, Kyoto, Japan, 606-8507
Contact: Junichi Matsubara, M.D., Ph.D.         
Sponsors and Collaborators
National Cancer Center, Japan
Eisai Co., Ltd.
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Responsible Party: National Cancer Center, Japan
ClinicalTrials.gov Identifier: NCT04962867    
Other Study ID Numbers: NCCH2006/MK010
First Posted: July 15, 2021    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Cancer Center, Japan:
E7090
Solid tumor
Fibroblast Growth Factor Receptor (FGFR)
FGFR inhibitor