drugset / Trial / NCT04008797
A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor
RandomizedSequentialOpen-labelTreatment
Summary
The primary objective of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s), and to determine the optimal dose of E7386 in combination with lenvatinib in endometrial carcinoma (EC) (for EC Dose Optimization Part only).
Timeline
- Start
- 2019-07-11
- Primary completion
- 2027-03-31
- Completion
- 2027-03-31
Publications
- Mesropian A, Gris-Oliver A, Balaseviciute U, Potdar AA, Kimura T, Shen J, Torres-Marcen M, Abril-Fornaguera J, Pique-Gili M, Camell-Raventos D, Peix J, Fernandez-Martinez E, Huguet-Pradell J, Hernandez de Sande A, Keraite I, Esteban-Fabro R, Barcena-Varela M, Lindblad KE, Lujambio A, Guccione E, Thung S, Ikeda M, Kudo M, Sia D, Pinyol R, Llovet JM. E7386 Enhances Lenvatinib's Antitumor Activity in Preclinical Models and Human Hepatocellular Carcinoma. Clin Cancer Res. 2025 Dec 1;31(23):5037-5050. doi: 10.1158/1078-0432.CCR-25-0725.
- Eskander RN, Lee JY, Mirza MR, Lorusso D, MacKay H, Ray-Coquard I, Oaknin A, Gonzalez-Martin A, Hasegawa K, Corr BR, Wu X, Leary A, Hu T, Dutta L, Okpara CE, McKenzie J, Makker V. Randomized study evaluating optimal dose, efficacy, and safety of E7386 plus lenvatinib versus treatment of physician's choice in advanced/recurrent endometrial carcinoma previously treated with platinum-based chemotherapy and immune checkpoint inhibitors. Int J Gynecol Cancer. 2025 Sep;35(9):101812. doi: 10.1016/j.ijgc.2025.101812. Epub 2025 Apr 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 60 mg/m2 | — |
| Subject | E7386 | Small molecule | 60 mg | Oral |
| Subject | E7386 | Small molecule | 120 mg | Oral |
| Subject | Lenvatinib | Small molecule | 8 mg | Oral |
| Subject | Lenvatinib | Small molecule | 12 mg | Oral |
| Subject | Lenvatinib | Small molecule | 14 mg | Oral |
| Subject | Lenvatinib | Small molecule | 20 mg | Oral |
| Subject | Lenvatinib | Small molecule | 24 mg | Oral |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | — |