NCT02491099 A Phase II Evaluation of Afatinib in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma
| NCT ID | NCT02491099 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Yale University |
| Condition | HER2/Neu+ Uterine Serous Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2015-06 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2015-06 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 \<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.
Contact & Investigator
Alessandro Santin, M.D.
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT02491099 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 100 Years, studying HER2/Neu+ Uterine Serous Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02491099 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT02491099 currently recruiting?
Yes, NCT02491099 is actively recruiting participants. Contact the research team at alessandro.santin@yale.edu for enrollment information.
Where is the NCT02491099 trial being conducted?
This trial is being conducted at Tucson, United States, New Haven, United States, Boston, United States.
Who is sponsoring the NCT02491099 clinical trial?
NCT02491099 is sponsored by Yale University. The principal investigator is Alessandro Santin, M.D. at Yale University. The trial plans to enroll 50 participants.