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NCT02491099
A Phase II Evaluation of Afatinib in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma
Conditions: HER2/Neu+ Uterine Serous Carcinoma
Sex: Female
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 50
Sponsor: Yale University
Location: University of Arizona Cancer Center Tucson Arizona
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.
Eligibility Criteria
Inclusion Criteria:
* Patients must have persistent or recurrent histologically confirmed uterine serous carcinoma, harbor a tumor HER2/neu+ based upon IHC staining score of 3+ or 2+ with confirmed gene amplification by FISH.
* Have measurable disease.
* Have at least one target lesion to be used to assess response as defined by RECIST v1.1.
* After undergoing surgery may be optimally or sub optimally debulked, with measurable recurrent disease of any previous substage.
* Diagnosis histologically confirmed by a gynecologic pathologist as containing \>10% uterine papillary serous adenocarcinoma in the specimen.
* Have adequate bone marrow function.
* WBC greater than or equal to 3,000/ul, platelets greater than or equal to 75,000/ul, neutrophils greater than or equal to 1500/ul., creatinine less than or equal to 2.0 mg/kl, bilirubin \< 1.5 X laboratory normal, SGOT/SGPT \
Source: ClinicalTrials.gov (NCT02491099). StuddyBuddy aggregates publicly available trial information.