Phase 1 Study of E7090 in Subjects With Solid Tumor

Tumors Clinical Trial

Official title:

A Phase 1 Study of E7090 in Subjects With Solid Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275910
• Other study ID #: E7090-J081-101
• Status: Completed
• Phase: Phase 1
• Start date: October 28, 2014
• Est. completion date: September 3, 2021

Study information

• Verified date: May 2021
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 3, 2021
• Est. primary completion date: September 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Tumors

Intervention

Drug:
• E7090

Locations

Country	Name	City	State
Japan	Eisai Trial Site #1	Amagasaki	Hyogo
Japan	Eisai Trial Site #1	Chiba
Japan	Eisai Trial Site #1	Chuo-Ku	Tokyo
Japan	Eisai Trial Site #1	Chuo-ku	Niigata
Japan	Eisai Trial Site #1	Fukuoka
Japan	Eisai Trial Site #1	Kashiwa	Chiba
Japan	Eisai Trial Site #1	Kawasaki	Kanagawa
Japan	Eisai Trial Site #1	Kitaadachi	Saitama
Japan	Eisai Trial Site #1	Koto-ku	Tokyo
Japan	Eisai Trial Site #1	Kyoto
Japan	Eisai Trial Site #1	Matsuyama	Ehime
Japan	Eisai Trial Site #1	Nagoya	Aichi
Japan	Eisai Trial Site #1	Osaka
Japan	Eisai Trial Site #2	Osaka
Japan	Eisai Trial Site #3	Osaka
Japan	Eisai Trial Site #1	Sapporo	Hokkaido
Japan	Eisai Trial Site #1	Tsukuba	Ibaraki
Japan	Eisai Trial Site #1	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of E7090 as a measure of Adverse Events/ Serious Adverse Events		Upto 30 days after last administration of drug
Secondary	Best Overall Response (BOR) in targeted population	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.	From screening until the date of discontinuation, assessed up to 100 months.
Secondary	Objective Response Rate (ORR)	ORR is defined as a proportion of subjects with BOR of CR or PR.	From screening until the date of discontinuation, assessed up to 100 months.
Secondary	Disease Control Rate (DCR)	DCR is defined as the proportion of subjects who with BOR of CR, PR or SD.	From screening until the date of discontinuation, assessed up to 100 months.
Secondary	Progression- Free Survival (PFS)	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).	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.
Secondary	Overall Survival (OS)	OS is defined as the time from the date of first dose to the date of death from any cause.	From the date of first dose until the date of death from any cause, assessed up to 100 months.
Secondary	Maximum tolerated Dose (MTD) of E7090 (part 1) and Recommended Dose (RD) for future studies		On day 35
Secondary	Plasma Cmax (maximum concentration) of E7090		On day 36
Secondary	Plasma tmax (Time of maximum concentration) of E7090		On day 36
Secondary	Plasma AUC (Area under the concentration vs time curve) of E7090		On day 36
Secondary	Pharmacokinetics (PK) of Urine (renal clearance)		On day 36