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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Afatinib Trial 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.Check my eligibility
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.See study design
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.

Afatinib Trial Eligibility Criteria

Inclusion Criteria

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

Afatinib Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival
Secondary outcome measures
The safety profile of Afatinib in USPC patients by CTCAE v4.0

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%
Dry skin
8%
Gamma-glutamyltransferase increased
8%
Abdominal pain upper
8%
Decreased appetite
8%
Weight decreased
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%
Malignant neoplasm progression
2%
Disease 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

Afatinib 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
~2340

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,841 Previous Clinical Trials
2,734,477 Total Patients Enrolled
Boehringer IngelheimIndustry Sponsor
2,497 Previous Clinical Trials
11,339,393 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks are associated with Afatinib consumption?

"Our team at Power believes that Afatinib has a safety rating of 2, as it is undergoing Phase 2 clinical trials with limited data supporting the drug's efficacy."

Answered by AI

How many individuals have enrolled in this research undertaking?

"The sponsor, Boehringer Ingelheim, necessitates 50 individuals that fulfil the study's eligibility requirements for this trial. To ensure participation from a diverse population of patients, recruitment will take place at multiple sites including Massachusetts General Hospital in Boston and Yale New Haven Hospital in Connecticut."

Answered by AI

Is this research project unprecedented in its approach?

"As of now, there are 36 ongoing research projects utilizing afatinib across 916 cities and 30 countries. The inaugural trial for the compound was conducted in 2012 by Boehringer Ingelheim with a sample size of 42 people who completed Phase 2 drug testing. Since then, 102 more trials have been concluded."

Answered by AI

Does the current trial protocol permit participation by individuals under 25 years old?

"The age range for those eligible to join this study is between 18 and 100 years old."

Answered by AI

Have any further investigations been conducted on Afatinib?

"Afatinib's first clinical trial took place in 2012 at Memorial Sloan Kettering Westchester, with a total of 102 trials completed since then. Currently, there are 36 active studies being conducted mainly around the Boston area."

Answered by AI

In what situations is Afatinib commonly prescribed?

"Afatinib can be used as a therapy for infectious diseases, second degree burns, and exons."

Answered by AI

Are there any unfilled slots in this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this experiment is presently searching for participants and was first published on June 1st 2015 before being updated most recently in February 2022. The requirement stands at 50 subjects across 3 clinics."

Answered by AI

Does my profile fulfill the requirements for participating in this research?

"This experiment is searching for 50 individuals aged 18 to 100 with erbb-2 receptor expression. The participants must have a RECIST v1.1 target lesion, measurable disease, an ECOG performance status of 0 or 1, no significant infection and adequate bone marrow function as well as histologically confirmed uterine serous carcinoma with IHC staining score 3+/FISH gene amplification 2+. Furthermore, they should be in optimal or suboptimal condition following surgery and possess written consent prior to joining the trial."

Answered by AI
Recent research and studies
~1 spots leftby Jul 2024