Clinical Trial - NCT02491099

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

Recruiting

Sponsor: Yale University

Collaborators: Boehringer Ingelheim

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02491099

Protocol Info

Short Description: Afatinib For Her2-Positive Uterine Serous Carcinoma
Long Description: 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
MGH Status: Open
Sponsor: Yale University
Disease Program: GYN

Next Steps


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Purpose

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.
Condition Title Intervention Phase
HER2/Neu+ Uterine Serous Carcinoma Afatinib Phase 2
Study Type Interventional
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

Primary Outcome Measures

Progression free survival [Time Frame: 4 Years] [Designated as safety issue: ]


Secondary Outcome Measures

The safety profile of Afatinib in USPC patients by CTCAE v4.0 [Time Frame: 4 Years] [Designated as safety issue: ]

Estimated Enrollment: 50
Study Start Date: June 2015
Estimated Study Completion Date: June 2028
Estimated Primary Completion Date: June 2023
Arms Assigned Interventions

Experimental:Afatinib

Afatinib 40 mgs., Q 21 Day times 4 Cycles
Drug: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

Eligibility

Ages Eligible for Study: 100 Years-100 Years

Genders Eligible for Study: Female

Accepts Healthly Volunteers: No

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, granulocytes 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.

Exclusion Criteria:

  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancers are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol.
  • 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02491099

Locations

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

Sponsors and Collaborators

Yale University

Boehringer Ingelheim

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02491099
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Carcinoma

Cystadenocarcinoma, Serous

Mitogens

Afatinib

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on August 15, 2019