Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)
Summary
The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.
Timeline
- Start
- 2014-09-25
- Primary completion
- 2016-05-13
- Completion
- 2016-08-25
Outcome
Mixed primary results
registry Placebo vs Nintedanib; p <0.0001; Hazard Ratio (HR) 0.58 (95% CI 0.49 to 0.69); Log Rank NCT02149108 ↗
registry Placebo vs Nintedanib; p = 0.8659; Hazard Ratio (HR) 1.01 (95% CI 0.86 to 1.19); Log Rank NCT02149108 ↗
release “LUME- Colon 1 trial, investigating nintedanib plus best supportive care (BSC) versus BSC alone, met one of the co-primary endpoints of progression-free survival (PFS)” prnewswire.com ↗
release “While nintedanib showed clear anti-tumor activity and significantly reduced the risk of disease progression by 42% versus BSC, this did not translate into an overall survival (OS) benefit” prnewswire.com ↗
Publications
- Van Cutsem E, Yoshino T, Lenz HJ, Lonardi S, Falcone A, Limon ML, Saunders M, Sobrero A, Park YS, Ferreiro R, Hong YS, Tomasek J, Taniguchi H, Ciardiello F, Stoehr J, Oum'Hamed Z, Vlassak S, Studeny M, Argiles G. Nintedanib for the treatment of patients with refractory metastatic colorectal cancer (LUME-Colon 1): a phase III, international, randomized, placebo-controlled study. Ann Oncol. 2018 Sep 1;29(9):1955-1963. doi: 10.1093/annonc/mdy241.
- Van Cutsem E, Yoshino T, Hocke J, Oum'Hamed Z, Studeny M, Tabernero J. Rationale and Design for the LUME-Colon 1 Study: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Nintedanib Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Colorectal Cancer Refractory to Standard Treatment. Clin Colorectal Cancer. 2016 Mar;15(1):91-94.e1. doi: 10.1016/j.clcc.2015.09.005. Epub 2015 Oct 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nintedanib | Small molecule | 200 mg | — |