Targeted pill aims to halt recurrent uterine cancer
NCT ID NCT02491099
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests the drug afatinib in 50 women with a rare, aggressive uterine cancer (HER2-positive uterine serous carcinoma) that has persisted or returned. Afatinib is a daily pill that blocks a protein driving cancer growth. The main goal is to see if it can keep the cancer from worsening for at least 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Afatinib (a targeted cancer pill)
- What this could lead to
- If successful, this could offer a new treatment option to slow or shrink HER2-positive uterine serous carcinoma that has returned or not responded to prior therapy.
- What could go wrong
- This is a small, early-phase trial (50 participants) with no control group. The drug may not improve outcomes and can cause side effects like diarrhea, rash, or mouth sores.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Jun 2015
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts General Hospital
COMPLETEDBoston, Massachusetts, 02114, United States
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University of Arizona Cancer Center
COMPLETEDTucson, Arizona, 85724, United States
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Yale New Haven Hospital
RECRUITINGNew Haven, Connecticut, 06510, United States