JPRN-jRCT2031210043
Active, not recruiting
Phase 2
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
Takahashi Masamichi0 sites45 target enrollmentApril 20, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- advanced or recurrent solid tumor with fibroblast growth factor receptor (FGFR) gene alteration
- Sponsor
- Takahashi Masamichi
- Enrollment
- 45
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Subjects 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 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
- •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
Exclusion Criteria
- •1\) Participants with brain or subdural metastases
- •2\) Participants with leptomeningeal metastasis
- •3\) Participants with primary spinal cord tumors
- •4\) Participants with primary CNS tumor located in either cerebellum, brainstem, pituitary gland, optic nerve or olfactory nerve
- •5\) 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)
- •6\) 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)
- •7\) Child\-Pugh score B or C
- •8\) Participants with pericardial effusion, pleural effusion, or ascites requiring treatment
- •9\) Have any of the following ocular diseases
- •a)Grade 2 or higher corneal disorders
Outcomes
Primary Outcomes
Not specified
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