← Back to Search

Tyrosine Kinase Inhibitor

Afatinib for Uterine Cancer (Afatinib Trial)

Phase 2
Recruiting
Led By Alessandro Santin, M.D.
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis histologically confirmed by a gynecologic pathologist as containing >10% uterine papillary serous adenocarcinoma in the specimen
Must be 18 years of age
Must not have
Patients with uncontrolled seizure disorder or active neurological disease
Patients who have received prior therapy with any irreversible human epidermal growth factor receptor tyrosine kinase inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing Afatinib, a drug used to treat other types of cancer, to see if it is effective in treating uterine serous carcinoma, a type of uterine cancer. The objectives are to see if the drug extends progression-free survival, overall survival, and has a good safety profile.

Who is the study for?
This trial is for adults with persistent or recurrent HER2-positive uterine serous carcinoma. Participants must have measurable disease, recovered from prior treatments, adequate organ and bone marrow function, and an ECOG performance status of 0 or 1. Women of childbearing age need a negative pregnancy test and must use contraception.
What is being tested?
The trial tests Afatinib's effectiveness in patients with HER2-positive uterine serous carcinoma by measuring progression-free survival at six months, overall response rate, durable disease control rate, overall survival, and safety profile.
What are the potential side effects?
While not explicitly listed here, common side effects of drugs like Afatinib may include diarrhea, skin rashes or acneiform eruptions (pimple-like bumps), mouth sores, loss of appetite and weight loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is mostly uterine papillary serous adenocarcinoma.
Select...
I am 18 years old or older.
Select...
My uterine cancer is HER2 positive, confirmed by specific tests.
Select...
My blood and liver tests meet the required levels.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have seizures or a brain condition that is not well-controlled.
Select...
I have been treated with a specific type of lung cancer medication before.
Select...
I do not have any unstable health issues or active severe conditions.
Select...
I have a bleeding disorder or a condition that causes excessive bleeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression free survival

Side effects data

From 2017 Phase 4 trial • 60 Patients • NCT02208843
73%
Diarrhoea
30%
Rash
23%
Paronychia
22%
Hypokalaemia
20%
Mucosal inflammation
20%
Anaemia
20%
Nausea
15%
Dermatitis acneiform
15%
Fatigue
10%
Vomiting
10%
Dermatitis
8%
Weight decreased
8%
Dry skin
8%
Gamma-glutamyltransferase increased
8%
Abdominal pain upper
8%
Decreased appetite
8%
Pruritus
8%
Stomatitis
8%
Hyponatraemia
7%
Hyperglycaemia
7%
Back pain
7%
Nail pitting
7%
Acne
7%
Dizziness
7%
Hypocalcaemia
7%
Leukopenia
7%
Hypomagnesaemia
7%
Cough
3%
Acute kidney injury
3%
Pneumonia
3%
Brain oedema
3%
Seizure
2%
Disease progression
2%
Malignant neoplasm progression
2%
Cardiac arrest
2%
Hemiparesis
2%
Nervous system disorder
2%
Deep vein thrombosis
2%
Blood creatinine increased
2%
Epilepsy
2%
Malignant pleural effusion
2%
Neurological decompensation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Afatinib 40 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AfatinibExperimental Treatment1 Intervention
Afatinib 40 mgs., Q 21 Day times 4 Cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Afatinib
2016
Completed Phase 4
~2330

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,394 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,552 Previous Clinical Trials
15,897,061 Total Patients Enrolled
Alessandro Santin, M.D.Principal InvestigatorYale University
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Afatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02491099 — Phase 2
Uterine Carcinoma Research Study Groups: Afatinib
Uterine Carcinoma Clinical Trial 2023: Afatinib Highlights & Side Effects. Trial Name: NCT02491099 — Phase 2
Afatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02491099 — Phase 2
~2 spots leftby Jul 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top