NCT02619162

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

Nintedanib Plus Letrozole in Postmenopausal Women With Breast Cancer: Clinical Trial Phase 0/1 Safety and Pharmacodynamics

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Centro Nacional de Investigaciones Oncologicas CARLOS III · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase 0 / I: At level 1 it includes three patients. If any patient suffers dose limiting toxicity (DLT), it proceeds to the increase in dose to the next level. If 2/3 patients experience DLT, he will close the increased dose and extended / investigate the previous dose level with 3 additional patients. If the level 2, but less than 1/3 the minimum of 6 patients experience TLD is reached, the phase I be suspended because not expected another rise above Level 2. Dose levels: * Level 1: Nintedanib 150 mg twice daily + oral letrozole 2.5 mg / day orally, in a cycle of 28 days. * Level 2: Nintedanib 200 mg twice daily via oral + letrozole 2.5 mg / day orally, in a cycle of 28 days. * At least the first cycle will be administered during Phase I. A total of six four-week cycles were administered at the discretion of the investigator.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Nintedanib	Tablets of 100 mg. or 150 mg.
DRUG	Letrozole	Tablet of 2.5 mg.

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-11-01
• Completion: 2018-06-01
• First posted: 2015-12-02
• Last updated: 2019-07-23

Locations

3 sites across 1 country: Spain