Phase 1 Study of E7090 in Subjects With Solid Tumor

A Phase 1 Study of E7090 in Subjects With Solid Tumor

This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be conducted in 2 parts:

1. Part 1 will be the dose escalation portion of this study to determine the maximum tolerated dose in subjects with solid tumors, and
2. Part 2 will comprise cohort expansions to further characterize the safety and tolerability of E7090 and to assess preliminary efficacy of E7090 in subjects with solid tumors characterized by genetic abnormalities in FGF/FGFR pathway.

Study Overview

• Status: Completed
• Conditions: Tumors
• Intervention / Treatment: Drug: E7090

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Chiba, Japan
    • Eisai Trial Site #1
  • Fukuoka, Japan
    • Eisai Trial Site #1
  • Kyoto, Japan
    • Eisai Trial Site #1
  • Osaka, Japan
    • Eisai Trial Site #1
  • Osaka, Japan
    • Eisai Trial Site #2
  • Osaka, Japan
    • Eisai Trial Site #3
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan
      • Eisai Trial Site #1
  • Chiba
    • Kashiwa, Chiba, Japan
      • Eisai Trial Site #1
  • Ehime
    • Matsuyama, Ehime, Japan
      • Eisai Trial Site #1
  • Hokkaido
    • Sapporo, Hokkaido, Japan
      • Eisai Trial Site #1
  • Hyōgo
    • Amagasaki, Hyōgo, Japan
      • Eisai Trial Site #1
  • Ibaraki
    • Tsukuba, Ibaraki, Japan
      • Eisai Trial Site #1
  • Kanagawa
    • Kawasaki, Kanagawa, Japan
      • Eisai Trial Site #1
    • Yokohama, Kanagawa, Japan
      • Eisai Trial Site #1
  • Niigata
    • Chuo-ku, Niigata, Japan
      • Eisai Trial Site #1
  • Saitama
    • Kitaadachi, Saitama, Japan
      • Eisai Trial Site #1
  • Tokyo
    • Chuo-Ku, Tokyo, Japan
      • Eisai Trial Site #1
    • Koto-ku, Tokyo, Japan
      • Eisai Trial Site #1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Part 1and Part 2

1. Provide written informed consent
2. Male or female subjects age >= 20 years at the time of informed consent
3. Subjects with a histological and/or cytological diagnosis of solid tumor
4. Subjects who failed standard therapies, or for which no appropriate treatment is available.
5. Subjects with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG)

6. Subjects who are expected to survive for 3 months or longer after starting administration of the investigational drug.

   Inclusion Criteria: Part 2 only

7. Subjects with tumor expressing genetic abnormality in FGF/FGFR (fibroblast growth factor/ fibroblast growth factor receptor)pathway.

Exclusion criteria

1. Patients with brain metastasis who have clinical symptoms or requiring treatment.
2. Medical history of clinically significant cardiovascular impairment
3. Concomitant systemic infection requiring medical treatment
4. Effusion requiring drainage
5. Known intolerance to the study drug (or any of excipients)
6. Subjects whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia).
7. Inability to take oral medication, or malabsorption syndrome, or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of E7090.
8. Psychiatric disorder (e.g., alcohol or drug dependency) judged to be ineligible for study entry by the investigator or subinvestigator
9. Females who are pregnant or breastfeeding
10. Any subjects who are judged by the principal investigator or the other investigators to be inappropriate as subjects in this clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: E7090 Arm; Oral, starting dose 1 mg once a day, dose escalation in part 1. Cycle 0 is for 7 days. For Cycle 1 and onward, each cycle is 28 days long. The Cycle 0 is set up for PK analysis of a single dose of E7090. In the following Cycle 1, subjects will be administered E7090 QD, and the PK and safety will be assessed for 28 days. One or two doses may be selected from part 1 for Part 2. E7090 will be administered continuously once a daily. Subjects can continue treatment unless they meet discontinuation criteria.

Drug: E7090

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)	DLT was graded using Common Terminology Criteria for Adverse Events version 4.03 as follows: a. febrile neutropenia, or Grade 4 neutropenia persisting for greater than or equal to (>=) 7 days, b. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia requiring platelet transfusions, c. Grade >=3 non-hematological toxicity, except for: clinically insignificant laboratory abnormalities, toxicity Grade less than or equal to (<=) 2 by best supportive care; d. potentially clinically significant, new radiographic mineralization in soft tissue, kidneys, intestines, heart, lungs, or other organs; e. Hyperphosphatemia meeting either for: serum phosphate level greater than (>) 7 milligram per deciliter (mg/dL) persisting for >=7 days despite best treatment, serum phosphate level >9 mg/dL despite best treatment; f. treatment interruption for >=8 days during Cycle 0; Cycle 1 required by E7090-related toxicity, except for treatment interruption for >=8 days for reasons other than toxicity.	Cycle 0 (Cycle length= 7 days) up to Cycle 1 (Cycle length= 28 days)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	A TEAE was defined as an adverse event (AE) that emerged during the time from the first dose of study drug to 30 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. A Serious AE is any untoward medical occurrence that at any dose: resulted in death; was life threatening (that is, the participant was at immediate risk of death from the AE as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death) required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.	From the start of study drug administration up to 2 year 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 2: Overall Survival (OS)	OS was defined as the time from the date of first dose to the date of death from any cause. OS was estimated by using Kaplan-Meier method.	From the date of first dose of study drug up to 2 years and 8 months
Part 2: Progression- Free Survival (PFS)	PFS was defined as the time from the date of first dose to the first documented date of event (disease progression or death from any cause, whichever occurs first). PD was defined as at least a 20 percent (%) increase in the sum of LD of target and non-target lesions as compared with the smallest sum of long diameter (LD) and the increase of LD was at least 5 millimeter (mm) (including new lesions). The tumor assessment is based on Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria and was estimated using Kaplan-Meier method.	From the date of first dose of study drug up to 2 years and 8 months
Best Overall Response (BOR)	Tumor assessment (target lesion, non-target lesion, and presence or absence of new lesion) was performed based on RECIST v1.1. Tumor marker was also measured. FDG-PET CT (fluorodeoxyglucose- Positron emission tomography computed tomography) also evaluated. Best overall responses were complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE). CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with baseline summed LD. SD was defined as no known evidence of progressive disease or new bone lesions where SD was achieved at >=7 weeks after first dose.	From the date of first dose of study drug up to 2 years and 8 months
Part 2: Objective Response Rate (ORR)	ORR was defined as a percentage of participants with BOR of CR or PR. ORR was assessed using RECIST 1.1. CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with baseline summed LD.	From screening up to 2 years and 8 months
Part 2: Disease Control Rate (DCR)	DCR was defined as the percentage of participants with BOR of CR, PR or SD. DCR was assessed based on RECIST 1.1. CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with Baseline summed LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. SD was defined as no known evidence of progressive disease or new bone lesions where SD was achieved at >= 7 weeks after first dose.	From the date of first dose of study drug up to 2 years and 8 months
Cmax: Maximum Observed Plasma Concentration for E7090		Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose; (Cycle 1 is 28 days)
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7090		Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose; (Cycle 1 is 28 days)
AUC(0-24h): Area Under the Plasma Concentration-time Curve From Zero Time to 24 Hours		Part 1: Cycle 0 Day 1: 0-24 hours post dose (Cycle 0 is 7 days); Part 2: Cycle 1 Day 1: 0-24 hours post dose (Cycle 1 is 28 days)
Part 1: CL/F: Apparent Total Clearance for E7090		Part 1: Cycle 0 Day 1: 0-72 hours post dose (Cycle 0 is 7 days)

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2014
• Primary Completion (Actual): September 3, 2021
• Study Completion (Actual): September 3, 2021

Study Registration Dates

• First Submitted: October 20, 2014
• First Submitted That Met QC Criteria: October 23, 2014
• First Posted (Estimated): October 27, 2014

Study Record Updates

• Last Update Posted (Estimated): December 16, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Solid Tumors; E7090
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: E7090-J081-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No