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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
E7090
Drug140 mg of E7090 is orally administered once daily.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
Baseline up to 3.5 yearsSecondary 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 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.
Time frame
Baseline up to 3.5 years2
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.
Time frame
Baseline up to 3.5 years3
Overall Survival (OS)
Overall survival (OS) defined as the time from date of enrollment to date of death due to any cause.
Time frame
Baseline up to 3.5 years4
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.
Time frame
Baseline up to 3.5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Cancer Center, Japan
Lead sponsor
Eisai Co., Ltd.
Collaborator
Source ClinicalTrials.gov