A phase I/II study of nintedanib and capecitabine for refractory metastatic colorectal cancer.

ABSTRACT:

Background

Nintedanib is a tyrosine kinase inhibitor with efficacy in bevacizumab-resistant colorectal cancer models. This phase I/II study evaluated the recommended phase II dose and efficacy of nintedanib and capecitabine in refractory metastatic colorectal cancer.

Methods

Key eligibility criteria included refractory metastatic colorectal cancer and ECOG performance status of 1 or lower. The primary endpoint was 18-week progression-free survival (PFS). A 1-sided binomial test (at α = .1) compared the observed 18-week PFS with a historic control of .25.

Results

Forty-two patients were enrolled, including 39 at the recommended phase II dose. The recommended phase II dose was established to be nintedanib 200 mg by mouth twice daily and capecitabine 1000 mg/m2 by mouth

SUBMITTER: Boland PM 

PROVIDER: S-EPMC11065487 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature