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RECRUITING
NCT02491099
PHASE2

A Phase II Evaluation of Afatinib in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma

Sponsor: Yale University

View on ClinicalTrials.gov

Summary

Primary Objective: To assess the activity of Afatinib in patients with persistent or recurrent uterine serous carcinoma overexpressing HER2/neu with the frequency of patients who survive progression-free for at least 6 months after initiating therapy. Secondary Objectives: To assess objective response rate and durable disease control rate. To assess overall survival. To assess the safety profile of Afatinib in uterine serous carcinoma patients.

Official title: A Phase II Evaluation of Afatanib, an Irreversible Human Epidermal Growth Factor Receptor 2 (Her2/Neu) Tyrosine Kinase Inhibitor, in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma

Key Details

Gender

FEMALE

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2015-06

Completion Date

2028-07

Last Updated

2025-10-09

Healthy Volunteers

No

Interventions

DRUG

Afatinib

Afatinib, 40 mg orally once daily on a 21 day cycle for the first 12 weeks, then every 28 days for subsequent cycles until progression

Locations (3)

University of Arizona Cancer Center

Tucson, Arizona, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Massachusetts General Hospital

Boston, Massachusetts, United States