Recruiting
Phase 2

Afatinib

Sponsor:

Yale University

Code:

NCT02491099

Conditions

HER2/Neu+ Uterine Serous Carcinoma

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Afatinib

Study Details

Brief 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.

Conditions

HER2/Neu+ Uterine Serous Carcinoma

Study ID

NCT02491099

Start date

Jun, 2015

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 <3 X laboratory normal.
  • Have an ECOG performance status of 0 or 1.
  • Have signed an approved consent.
  • Have recovered from effects of recent surgery, radiotherapy or chemotherapy. Should be free of significant infection.
  • Patients with recurrent disease may have received multiple prior chemotherapies for treatment of their uterine cancer.
  • May have received prior trastuzumab therapy alone or in combination with chemotherapy with 2 week washout period required between trastuzumab treatment and first dose of Afatanib.
  • Patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the study entry and be practicing an effective form of contraception.
  • Must be 18 years of age.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. NOTE: Patients with prior anthracycline exposure are NOT eligible.

Exclusion Criteria:

  • Patients who have a significant history of cardiac disease, uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, or uncontrolled arrhythmias within 6 months of registration. Patients with any unstable medical issue, active treatment for symptomatic pulmonary embolism, CVA, renal or hepatic insufficiency, active infection/sepsis requiring IV antibiotics, known brain/leptomengial involvement of the disease, active neurological disease, dementia.
  • Patients who have received prior therapy with any irreversible human epidermal growth factor receptor tyrosine kinase inhibitor.
  • Patients who have an uncontrolled seizure disorder or active neurological disease. Patients known to be seropositive for HIV and active hepatitis, even if liver function studies are in the eligible range. Known hemorrhagic diathesis or active bleeding disorder.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Afatinib

Afatinib 40 mgs., Q 21 Day times 4 Cycles

Interventions

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

Primary outcome measure

  • Progression free survival [ Time Frame: 4 Years ]

Central Contacts and Locations

Central contacts

Alessandro D. Santin, M.D.

203-737-4450alessandro.santin@yale.edu

Lisa Baker, R.N.

203-785-6398lisa.baker@yale.edu

Locations

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Alessandro D. Santin, M.D.

203-737-4450alessandro.santin@yale.edu

Lisa Baker, R.N.

203-785-6398lisa.baker@yale.edu

More Information

Sponsor

Yale University

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-22.