A Study of Efficacy and Safety of Fruquintinib (HMPL-013) in Participants With Metastatic Colorectal Cancer

Summary

This is a global, randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial to compare the efficacy and safety of fruquintinib plus best supportive care (BSC) versus placebo plus BSC in participants with refractory metastatic colorectal cancer (mCRC). 691 participants were randomized to one of the following treatment arms in a 2:1 ratio, fruquintinib plus BSC or placebo plus BSC.

Timeline

Start

2020-08-12

Primary completion

2022-07-29

Completion

2024-04-24

Publications

• Kotani D, Yoshino T, Masuishi T, Sunakawa Y, Takashima A, Yamazaki K, Kawakami H, Nishina T, Komatsu Y, Esaki T, Eng C, Ukrainskyj S, Pallai R, Nanda S, Yang Z, Schelman W, Kania M, Satoh T. Efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer: a FRESCO-2 subgroup analysis of patients enrolled in Japan. Int J Clin Oncol. 2025 Oct;30(10):2043-2052. doi: 10.1007/s10147-025-02852-9. Epub 2025 Sep 1.
• Zhou X, Toms A, Morton D, Wang X, Taylor A, Dasari A, Gupta N, Chien C. Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer. J Clin Pharmacol. 2025 Nov;65(11):1411-1419. doi: 10.1002/jcph.70051. Epub 2025 Jun 8.
• Eng C, Dasari A, Lonardi S, Garcia-Carbonero R, Elez E, Yoshino T, Sobrero A, Yao J, Garcia-Alfonso P, Kocsis J, Gracian AC, Sartore-Bianchi A, Satoh T, Randrian V, Tomasek J, Chong G, Yang Z, Guevara F, Schelman W, Pallai R, Tabernero J. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer: safety analysis of FRESCO-2. Oncologist. 2025 Mar 10;30(3):oyae360. doi: 10.1093/oncolo/oyae360.
• Sobrero A, Dasari A, Aquino J, Lonardi S, Garcia-Carbonero R, Elez E, Yoshino T, Yao J, Garcia-Alfonso P, Kocsis J, Gracian AC, Sartore-Bianchi A, Satoh T, Randrian V, Tomasek J, Chong G, Price T, Yu Z, Geiger A, Chen L, Yang Z, Schelman WR, Kania M, Tabernero J, Eng C. Health-related quality of life associated with fruquintinib in patients with metastatic colorectal cancer: Results from the FRESCO-2 study. Eur J Cancer. 2025 Mar 11;218:115268. doi: 10.1016/j.ejca.2025.115268. Epub 2025 Jan 29.
• Dasari A, Lonardi S, Garcia-Carbonero R, Elez E, Yoshino T, Sobrero A, Yao J, Garcia-Alfonso P, Kocsis J, Cubillo Gracian A, Sartore-Bianchi A, Satoh T, Randrian V, Tomasek J, Chong G, Paulson AS, Masuishi T, Jones J, Csoszi T, Cremolini C, Ghiringhelli F, Shergill A, Hochster HS, Krauss J, Bassam A, Ducreux M, Elme A, Faugeras L, Kasper S, Van Cutsem E, Arnold D, Nanda S, Yang Z, Schelman WR, Kania M, Tabernero J, Eng C; FRESCO-2 Study Investigators. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study. Lancet. 2023 Jul 1;402(10395):41-53. doi: 10.1016/S0140-6736(23)00772-9. Epub 2023 Jun 15.
• Dasari A, Sobrero A, Yao J, Yoshino T, Schelman W, Yang Z, Chien C, Kania M, Tabernero J, Eng C. FRESCO-2: a global Phase III study investigating the efficacy and safety of fruquintinib in metastatic colorectal cancer. Future Oncol. 2021 Aug;17(24):3151-3162. doi: 10.2217/fon-2021-0202. Epub 2021 May 17.

Drugs

Indications