Phase 1 Study of E7090 in Subjects With Solid Tumor

NCT02275910 | Completed Phase 1 Results DMC

• 1 other identifier: E7090-J081-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 18

Brief Summary

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

1. 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. 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.

Conditions

Tumors

Keywords

Solid Tumors; E7090

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Part 2: Overall Survival (OS)

  From the date of first dose of study drug up to 2 years and 8 months

• Part 2: Progression- Free Survival (PFS)

  From the date of first dose of study drug up to 2 years and 8 months

• Best Overall Response (BOR)

  From the date of first dose of study drug up to 2 years and 8 months

• Part 2: Objective Response Rate (ORR)

  From screening up to 2 years and 8 months

• Part 2: Disease Control Rate (DCR)

  From the date of first dose of study drug up to 2 years and 8 months

Study Arms (1)

E7090 Arm

EXPERIMENTAL

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

Interventions

E7090 DRUG

E7090 Arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent
• Male or female subjects age \>= 20 years at the time of informed consent
• Subjects with a histological and/or cytological diagnosis of solid tumor
• Subjects who failed standard therapies, or for which no appropriate treatment is available.
• Subjects with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG)
• Subjects who are expected to survive for 3 months or longer after starting administration of the investigational drug.
• Subjects with tumor expressing genetic abnormality in FGF/FGFR (fibroblast growth factor/ fibroblast growth factor receptor)pathway.

You may not qualify if:

• Patients with brain metastasis who have clinical symptoms or requiring treatment.
• Medical history of clinically significant cardiovascular impairment
• Concomitant systemic infection requiring medical treatment
• Effusion requiring drainage
• Known intolerance to the study drug (or any of excipients)
• Subjects whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia).
• 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.
• Psychiatric disorder (e.g., alcohol or drug dependency) judged to be ineligible for study entry by the investigator or subinvestigator
• Females who are pregnant or breastfeeding
• Any subjects who are judged by the principal investigator or the other investigators to be inappropriate as subjects in this clinical study.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (18)

Eisai Trial Site #1

Nagoya, Aichi-ken, Japan

Location

Eisai Trial Site #1

Kashiwa, Chiba, Japan

Location

Eisai Trial Site #1

Matsuyama, Ehime, Japan

Location

Eisai Trial Site #1

Sapporo, Hokkaido, Japan

Location

Eisai Trial Site #1

Amagasaki, Hyōgo, Japan

Location

Eisai Trial Site #1

Tsukuba, Ibaraki, Japan

Location

Eisai Trial Site #1

Kawasaki, Kanagawa, Japan

Location

Eisai Trial Site #1

Yokohama, Kanagawa, Japan

Location

Eisai Trial Site #1

Chuo-ku, Niigata, Japan

Location

Eisai Trial Site #1

Kitaadachi, Saitama, Japan

Location

Eisai Trial Site #1

Chuo-Ku, Tokyo, Japan

Location

Eisai Trial Site #1

Koto-ku, Tokyo, Japan

Location

Eisai Trial Site #1

Chiba, Japan

Location

Eisai Trial Site #1

Fukuoka, Japan

Location

Eisai Trial Site #1

Kyoto, Japan

Location

Eisai Trial Site #1

Osaka, Japan

Location

Eisai Trial Site #2

Osaka, Japan

Location

Eisai Trial Site #3

Osaka, Japan

Location

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Eisai Inquiry Service.
• Organization: Eisai Co., Ltd.

eisai-chiken_hotline@hhc.eisai.co.jp

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 27, 2014
• Study Start: October 28, 2014
• Primary Completion: September 3, 2021
• Study Completion: September 3, 2021
• Last Updated: December 16, 2025
• Results First Posted: December 16, 2025

Record last verified: 2025-11

Locations

JP (18)