A Phase II Evaluation of Afatinib in Patients With Persistent or Recurrent HER2-positive U
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
| Condition(s) | HER2/Neu+ Uterine Serous Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Lead sponsor | Yale University |
| Locations | Tucson, Arizona, United States; New Haven, Connecticut, United States; Boston, Massachusetts, United States |
| Start date | 2015-06 |
| NCT ID | NCT02491099 |
| Official listing | https://clinicaltrials.gov/study/NCT02491099 |