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Afatinib for Uterine Cancer (Afatinib Trial)
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.
Afatinib Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAfatinib Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 4 trial • 60 Patients • NCT02208843Afatinib Trial Design
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Who is running the clinical trial?
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- My cancer is mostly uterine papillary serous adenocarcinoma.I have had several treatments for my recurring uterine cancer.I am 18 years old or older.I have seizures or a brain condition that is not well-controlled.I had surgery for my cancer, and it has come back.I have been treated with a specific type of lung cancer medication before.My uterine cancer is HER2 positive, confirmed by specific tests.My blood and liver tests meet the required levels.I am fully active or restricted in physically strenuous activity but can do light work.I have not had any cancer except for non-melanoma skin cancer in the last 5 years.I do not have any unstable health issues or active severe conditions.I have had trastuzumab treatment but stopped before starting Afatinib.I have not had serious heart issues or uncontrolled blood pressure in the last 6 months.I have a bleeding disorder or a condition that causes excessive bleeding.I have recovered from recent surgery, radiotherapy, or chemotherapy and do not have a significant infection.
- Group 1: Afatinib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
In what situations is Afatinib commonly prescribed?
"Afatinib can be used as a therapy for infectious diseases, second degree burns, and exons."
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."
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."
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