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New treatment option for HER2/Neu+ Uterine Serous Carcinoma
Official title A Phase II Evaluation of Afatinib in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma
ClinicalTrials.gov ID: NCT02491099
What this study is testing
What is Afatinib?
Afatinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for her2/neu+ uterine serous carcinoma.
Also referred to as Irreversible Human Epidermal Growth Factor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100, women only
You may be able to join if
- Patients must have persistent or recurrent histologically confirmed uterine serous carcinoma, harbor a tumor HER2/neu+ based upon IHC staining score...
- 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.
You likely can't join if
- Patients who have a significant history of cardiac disease, uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure, or...
- 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...
See the full eligibility 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...
- 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 how well it works assessment of the investigational regimen are eligible for...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- New Haven, Connecticut, United States
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; New Haven, Connecticut, United States; Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.