Clinical trial NCT02275910: Phase 1 Study of E7090 in Subjects With Solid Tumor
Official title: A Phase 1 Study of E7090 in Subjects With Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Keywords: Solid Tumors
E7090
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-27
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and tolerability of E7090 as a measure of Adverse Events/ Serious Adverse Events
timeFrame: Upto 30 days after last administration of drug
Secondary outcomes:
measure: Best Overall Response (BOR) in targeted population
timeFrame: From screening until the date of discontinuation, assessed up to 100 months.
measure: Objective Response Rate (ORR)
timeFrame: From screening until the date of discontinuation, assessed up to 100 months.
measure: Disease Control Rate (DCR)
timeFrame: From screening until the date of discontinuation, assessed up to 100 months.
measure: Progression- Free Survival (PFS)
timeFrame: 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.
measure: Overall Survival (OS)
timeFrame: From the date of first dose until the date of death from any cause, assessed up to 100 months.
measure: Maximum tolerated Dose (MTD) of E7090 (part 1) and Recommended Dose (RD) for future studies
timeFrame: On day 35
measure: Plasma Cmax (maximum concentration) of E7090
timeFrame: On day 36
measure: Plasma tmax (Time of maximum concentration) of E7090
timeFrame: On day 36
measure: Plasma AUC (Area under the concentration vs time curve) of E7090
timeFrame: On day 36
measure: Pharmacokinetics (PK) of Urine (renal clearance)
timeFrame: On day 36
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Eisai Trial Site #1
state: Aichi
city: Kashiwa
country: Japan
facility: Eisai Trial Site #1
state: Chiba
city: Matsuyama
country: Japan
facility: Eisai Trial Site #1
state: Ehime
city: Sapporo
country: Japan
facility: Eisai Trial Site #1
state: Hokkaido
city: Amagasaki
country: Japan
facility: Eisai Trial Site #1
state: Hyogo
city: Tsukuba
country: Japan
facility: Eisai Trial Site #1
state: Ibaraki
city: Kawasaki
country: Japan
facility: Eisai Trial Site #1
state: Kanagawa
city: Yokohama
country: Japan
facility: Eisai Trial Site #1
state: Kanagawa
city: Chuo-ku
country: Japan
facility: Eisai Trial Site #1
state: Niigata
city: Kitaadachi
country: Japan
facility: Eisai Trial Site #1
state: Saitama
city: Chuo-Ku
country: Japan
facility: Eisai Trial Site #1
state: Tokyo
city: Koto-ku
country: Japan
facility: Eisai Trial Site #1
state: Tokyo
city: Chiba
country: Japan
facility: Eisai Trial Site #1
city: Fukuoka
country: Japan
facility: Eisai Trial Site #1
city: Kyoto
country: Japan
facility: Eisai Trial Site #1
city: Osaka
country: Japan
facility: Eisai Trial Site #1
city: Osaka
country: Japan
facility: Eisai Trial Site #2
city: Osaka
country: Japan
facility: Eisai Trial Site #3
Study officials:
References: