NCCH2006/MK010 Trial (FORTUNE Trial)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Cancer Center, Japan
About this 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).
Eligibility criteria
Qualifiers
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
For Group D, participants with cholangiocarcinoma who have previously received a selective FGFR inhibitor other than E7090 and have demonstrated progressive disease or resistance
Disqualifiers
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)
Trial design
Treatments tested in this trial
- E7090
Treatment groups
No treatment groups listed
Sponsors and collaborators
National Cancer Center, Japan
Lead sponsor
Eisai Co., Ltd.
Collaborator
Source ClinicalTrials.gov