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

NCT02619162 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-07-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Nintedanib

Tablets of 100 mg. or 150 mg.

DRUG

Letrozole

Tablet of 2.5 mg.

Sponsors & Collaborators

  • Dr. Miguel Angel Quintela Fandiño (CNIO)

    collaborator UNKNOWN

  • Dr, Ramón Colomer i Bosch

    collaborator UNKNOWN

  • FUNDACIÓN CRIS (Marta Cardona) as promotor

    collaborator UNKNOWN

  • Centro Nacional de Investigaciones Oncologicas CARLOS III

    lead OTHER

Principal Investigators

  • Marta Cardona · Fundacion CRIS de Investigación para Vencer el Cáncer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-11-30
Completion
2018-06-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02619162 on ClinicalTrials.gov