RECRUITING

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

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Conditions

HER2/Neu+ Uterine Serous Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2015-06
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02491099

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Have measurable disease.
  3. * Have at least one target lesion to be used to assess response as defined by RECIST v1.1.
  4. * After undergoing surgery may be optimally or sub optimally debulked, with measurable recurrent disease of any previous substage.
  5. * Diagnosis histologically confirmed by a gynecologic pathologist as containing \>10% uterine papillary serous adenocarcinoma in the specimen.
  6. * Have adequate bone marrow function.
  7. * 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.
  8. * Have an ECOG performance status of 0 or 1.
  9. * Have signed an approved consent.
  10. * Have recovered from effects of recent surgery, radiotherapy or chemotherapy. Should be free of significant infection.
  11. * Patients with recurrent disease may have received multiple prior chemotherapies for treatment of their uterine cancer.
  12. * 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.
  13. * 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.
  14. * Must be 18 years of age.
  15. * 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.
  1. * 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.
  2. * Patients who have received prior therapy with any irreversible human epidermal growth factor receptor tyrosine kinase inhibitor.
  3. * 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.

Contacts and Locations

Study Contact

Alessandro D. Santin, M.D.
CONTACT
203-737-4450
alessandro.santin@yale.edu
Lisa Baker, R.N.
CONTACT
203-785-6398
lisa.baker@yale.edu

Principal Investigator

Alessandro Santin, M.D.
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

University of Arizona Cancer Center
Tucson, Arizona, 85724
United States
Yale New Haven Hospital
New Haven, Connecticut, 06510
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Yale University

  • Alessandro Santin, M.D., PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-06
Study Completion Date2025-07

Study Record Updates

Study Start Date2015-06
Study Completion Date2025-07

Terms related to this study

Additional Relevant MeSH Terms

  • HER2/Neu+ Uterine Serous Carcinoma