Study of E7389 Liposomal Formulation in Participants With Solid Tumor

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.

Timeline

Start

2017-08-18

Primary completion

2018-07-19

Completion

2027-03-31

Publications

• Masuda N, Ono M, Mukohara T, Yasojima H, Shimoi T, Kobayashi K, Harano K, Mizutani M, Tanioka M, Takahashi S, Kogawa T, Suzuki T, Okumura S, Takase T, Nagai R, Semba T, Zhao ZM, Ren M, Yonemori K. Phase 1 study of the liposomal formulation of eribulin (E7389-LF): Results from the breast cancer expansion cohort. Eur J Cancer. 2022 Jun;168:108-118. doi: 10.1016/j.ejca.2022.03.004. Epub 2022 Apr 29.
• Sato J, Shimizu T, Koyama T, Iwasa S, Shimomura A, Kondo S, Kitano S, Yonemori K, Fujiwara Y, Tamura K, Suzuki T, Takase T, Nagai R, Yamaguchi K, Semba T, Zhao ZM, Ren M, Yamamoto N. Dose Escalation Data from the Phase 1 Study of the Liposomal Formulation of Eribulin (E7389-LF) in Japanese Patients with Advanced Solid Tumors. Clin Cancer Res. 2022 May 2;28(9):1783-1791. doi: 10.1158/1078-0432.CCR-21-3518.

Drugs

Indications