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ACTIVE NOT RECRUITING
NCT03207672
PHASE1

Study of E7389 Liposomal Formulation in Participants With Solid Tumor

Sponsor: Eisai Co., Ltd.

View on ClinicalTrials.gov

Summary

The maximum tolerated dose (MTD) of E7389 liposomal formulation (E7389-LF) will be determined in the dose escalation part. Safety, pharmacokinetics (PK) and efficacy will be assessed using treatment regimen evaluated in dose escalation part in participants with breast cancer (up to 3 prior regimens of chemotherapy) in the expansion part 1 and in participants with adenoid cystic carcinoma (ACC), gastric cancer (GC), esophageal cancer (EGC), small cell lung cancer (SCLC) and breast cancer (with no prior regimens of chemotherapy) in the expansion part 2, 3, 4, 5 and 6 respectively.

Official title: An Open-label Phase 1 Study of E7389 Liposomal Formulation in Subjects With Solid Tumor

Key Details

Gender

All

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2017-08-18

Completion Date

2027-03-31

Last Updated

2026-03-03

Healthy Volunteers

No

Conditions

Interventions

DRUG

E7389-LF

intravenous infusion

Locations (12)

Eisai Trial Site 3

Kashiwa, Chiba, Japan

Eisai Trial Site 5

Sapporo, Hokkaido, Japan

Eisai Trial Site 8

Nishinomiya, Hyōgo, Japan

Eisai Trial Site 6

Yokohama, Kanagawa, Japan

Eisai Trial Site 10

Hidaka, Saitama, Japan

Eisai Trial Site 9

Bunkyo-ku, Tokyo, Japan

Eisai Trial Site 1

Chuo-ku, Tokyo, Japan

Eisai Trial Site 4

Koto-ku, Tokyo, Japan

Eisai Trial Site 7

Shinjuku-ku, Tokyo, Japan

Eisai Trial Site 12

Fukuoka, Japan

Eisai Trial Site 11

Kyoto, Japan

Eisai Trial Site 2

Osaka, Japan