Trials / Active Not Recruiting

Active Not RecruitingNCT03207672

Study of E7389 Liposomal Formulation in Participants With Solid Tumor

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

Status: Active Not Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 140 (estimated)

Sponsor: Eisai Co., Ltd. · Industry
Sex: All
Age: 20 Years
Healthy volunteers: Not accepted

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.

Conditions

Solid Tumor

Interventions

Type	Name	Description
DRUG	E7389-LF	intravenous infusion

Timeline

Start date: 2017-08-18
Primary completion: 2018-07-19
Completion: 2027-03-31
First posted: 2017-07-05
Last updated: 2026-03-03

Locations

12 sites across 1 country: Japan

Source: ClinicalTrials.gov record NCT03207672. Inclusion in this directory is not an endorsement.