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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
75
140 mg of E7090 is orally administered once daily.
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, Japan
RECRUITINGKanagawa Cancer Center
Yokohama, Kanagawa, Japan
RECRUITINGTohoku University Hospital
Aoba-ku, Sendai, Miyagi, Japan
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 years
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 years
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 years
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 years
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 years
Adverse event (AE) rate
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Kyushu University Hospital
Higashi-Ku, Fukuoka, Japan
RECRUITINGHokkaido University Hospital
Kita-Ku, Sapporo, Hokkaido, Japan
RECRUITINGOkayama University Hospital
Okayama, Japan
RECRUITINGKyoto University Hospital
Sakyo-ku, Kyoto, Japan
RECRUITINGDefined 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).
Time frame: From the first dose of the investigational product until 30 days after the last dose of study drugs
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).
Time frame: From the first dose of the investigational product until 30 days after the last dose of study drugs
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.
Time frame: Baseline up to 3.5 years
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.
Time frame: Baseline up to 3.5 years