Nintedanib+Letrozole in Postmenopausal Women With Breast Cancer: Clinical Trial Safety and Pharmacodynamics

NCT02619162 ↗

Phase 1 Completed 25 enrolled Spanish National Cancer Research Centre Dr, Ramón Colomer i Bosch · collab Dr. Miguel Angel Quintela Fandiño (CNIO) · collab FUNDACIÓN CRIS (Marta Cardona) as promotor · collab

NaSingle-groupOpen-labelTreatment

Summary

Open, multicenter phase I with gradual increase in dosage to evaluate the safety and tolerability of orally administered nintedanib plus letrozole orally (2.5 mg / day) for patients with breast cancer. Nintedanib is administered twice a day orally for 28 consecutive days (Days 1-28) in 4-week cycles.

Timeline

Start: 2015-07
Primary completion: 2017-11
Completion: 2018-06

Publications

Quintela-Fandino M, Apala JV, Malon D, Mouron S, Hornedo J, Gonzalez-Cortijo L, Colomer R, Guerra J. Nintedanib plus letrozole in early breast cancer: a phase 0/I pharmacodynamic, pharmacokinetic, and safety clinical trial of combined FGFR1 and aromatase inhibition. Breast Cancer Res. 2019 May 24;21(1):69. doi: 10.1186/s13058-019-1152-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Letrozole	Other / unclassified	2.5 mg	Oral
Subject	Nintedanib	Small molecule	150 mg	Oral
Subject	Nintedanib	Small molecule	200 mg	Oral

Nintedanib+Letrozole in Postmenopausal Women With Breast Cancer: Clinical Trial Safety and Pharmacodynamics

Summary

Timeline

Publications

Drugs

Indications