- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02275910
Phase 1 Study of E7090 in Subjects With Solid Tumor
September 23, 2021 updated by: Eisai Co., Ltd.
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:
- Part 1 will be the dose escalation portion of this study to determine the maximum tolerated dose in subjects with solid tumors, and
- 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
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chiba, Japan
- Eisai Trial Site #1
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Fukuoka, Japan
- Eisai Trial Site #1
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Kyoto, Japan
- Eisai Trial Site #1
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Osaka, Japan
- Eisai Trial Site #1
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Osaka, Japan
- Eisai Trial Site #2
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Osaka, Japan
- Eisai Trial Site #3
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Aichi
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Nagoya, Aichi, Japan
- Eisai Trial Site #1
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Chiba
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Kashiwa, Chiba, Japan
- Eisai Trial Site #1
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Ehime
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Matsuyama, Ehime, Japan
- Eisai Trial Site #1
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Hokkaido
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Sapporo, Hokkaido, Japan
- Eisai Trial Site #1
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Hyogo
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Amagasaki, Hyogo, Japan
- Eisai Trial Site #1
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Ibaraki
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Tsukuba, Ibaraki, Japan
- Eisai Trial Site #1
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Kanagawa
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Kawasaki, Kanagawa, Japan
- Eisai Trial Site #1
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Yokohama, Kanagawa, Japan
- Eisai Trial Site #1
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Niigata
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Chuo-ku, Niigata, Japan
- Eisai Trial Site #1
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Saitama
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Kitaadachi, Saitama, Japan
- Eisai Trial Site #1
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Tokyo
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Chuo-Ku, Tokyo, Japan
- Eisai Trial Site #1
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Koto-ku, Tokyo, Japan
- Eisai Trial Site #1
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria: Part 1and Part 2
- 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.
Inclusion Criteria: Part 2 only
- Subjects with tumor expressing genetic abnormality in FGF/FGFR (fibroblast growth factor/ fibroblast growth factor receptor)pathway.
Exclusion criteria
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Safety and tolerability of E7090 as a measure of Adverse Events/ Serious Adverse Events
Time Frame: Upto 30 days after last administration of drug
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Upto 30 days after last administration of drug
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Best Overall Response (BOR) in targeted population
Time Frame: From screening until the date of discontinuation, assessed up to 100 months.
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Tumor assessment (target lesion, non-target lesion, and presence or absence of new lesion) will be performed based on RECIST v1.1 (Response Evaluation Criteria In Solid Tumors).
Tumor marker will also be measured.
FDG-PET CT (fluorodeoxyglucose- Positron emission tomography computed tomography) will also be evaluated.
Best overall response are complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE), where SD have to be achieved at >= 7 weeks after first dose.
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From screening until the date of discontinuation, assessed up to 100 months.
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Objective Response Rate (ORR)
Time Frame: From screening until the date of discontinuation, assessed up to 100 months.
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ORR is defined as a proportion of subjects with BOR of CR or PR.
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From screening until the date of discontinuation, assessed up to 100 months.
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Disease Control Rate (DCR)
Time Frame: From screening until the date of discontinuation, assessed up to 100 months.
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DCR is defined as the proportion of subjects who with BOR of CR, PR or SD.
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From screening until the date of discontinuation, assessed up to 100 months.
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Progression- Free Survival (PFS)
Time Frame: From the date of first dose until the first documented date of event (disease progression or death from any cause), assessed up to 100 months.
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PFS is 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).
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From the date of first dose until the first documented date of event (disease progression or death from any cause), assessed up to 100 months.
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Overall Survival (OS)
Time Frame: From the date of first dose until the date of death from any cause, assessed up to 100 months.
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OS is defined as the time from the date of first dose to the date of death from any cause.
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From the date of first dose until the date of death from any cause, assessed up to 100 months.
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Maximum tolerated Dose (MTD) of E7090 (part 1) and Recommended Dose (RD) for future studies
Time Frame: On day 35
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On day 35
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Plasma Cmax (maximum concentration) of E7090
Time Frame: On day 36
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On day 36
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Plasma tmax (Time of maximum concentration) of E7090
Time Frame: On day 36
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On day 36
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Plasma AUC (Area under the concentration vs time curve) of E7090
Time Frame: On day 36
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On day 36
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Pharmacokinetics (PK) of Urine (renal clearance)
Time Frame: On day 36
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On day 36
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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 (Estimate)
October 27, 2014
Study Record Updates
Last Update Posted (Actual)
September 28, 2021
Last Update Submitted That Met QC Criteria
September 23, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E7090-J081-101
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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