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Tyrosine Kinase Inhibitor

Afatinib for Cancer

Phase 2
Waitlist Available
Led By Philippe L Bedard
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have =< grade 1 diarrhea at baseline
In-frame insertions in exon 20 will be considered an activating mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
Awards & highlights

Study Summary

This trial is testing the effects of afatinib in patients with cancer that has HER2 mutations. Afatinib may stop cancer cell growth by blocking the HER2 receptor. Researchers hope to learn if afatinib will shrink or stop the growth of this type of cancer.

Who is the study for?
This trial is for cancer patients with specific HER2 genetic changes. They must have normal heart function, controlled diarrhea, and adequate kidney function. People with hypersensitivity to afatinib, lung disease history, or previous treatment with certain tyrosine kinase inhibitors are excluded.Check my eligibility
What is being tested?
The trial tests Afatinib Dimaleate's effectiveness on cancers with HER2 mutations. It aims to see if this drug can shrink the tumors or halt their growth by blocking a protein essential for cancer cell development.See study design
What are the potential side effects?
Afatinib may cause side effects such as diarrhea and skin reactions. Since it targets specific proteins in cancer cells, there might also be risks of abnormal liver tests, breathing problems, and potential heart issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I currently have mild or no diarrhea.
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My cancer has a specific genetic change in exon 20.
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My recent ECG showed no significant heart issues.
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My tumor has an activating HER2 mutation.
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My heart's pumping ability is within the normal range according to recent tests.
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My kidney function is good, meeting the trial's specific criteria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
6-month Progression-free Survival (PFS) Rate
Progression Free Survival (PFS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (afatinib dimaleate)Experimental Treatment1 Intervention
Patients receive afatinib dimaleate PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Afatinib Dimaleate
2015
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,601 Total Patients Enrolled
Philippe L BedardPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Afatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04439136 — Phase 2
Cancer Research Study Groups: Treatment (afatinib dimaleate)
Cancer Clinical Trial 2023: Afatinib Highlights & Side Effects. Trial Name: NCT04439136 — Phase 2
Afatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04439136 — Phase 2

Frequently Asked Questions

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

What precedent has been established with Afatinib Dimaleate in clinical research?

"To date, there are 32 active Afatinib Dimaleate studies with two of them having reached phase 3. Nagoya-shi, Aichi has a few trials dedicated to this molecule; however, it is being researched across 2059 clinical sites worldwide."

Answered by AI

What is the number of participants in this trial?

"This trial has already concluded recruitment, with the initial posting on August 12th 2015 and the last edit on October 31st 2020. However, if you are seeking alternate studies for refractory plasma cell myeloma there are currently 4663 clinical trials enrolling patients; 32 of which involve Afatinib Dimaleate."

Answered by AI

Is this experimental program currently seeking out participants?

"This research initiative is no longer recruiting participants. It was initially posted on August 12th, 2015 and its latest update occured on October 31st, 2022. If you're exploring alternative studies, there are currently 4663 medical trials that accept patients with refractory plasma cell myeloma while 32 studies are admitting individuals to be treated with afatinib dimaleate"

Answered by AI

Has Afatinib Dimaleate received verification from the Food and Drug Administration?

"Due to the lack of evidence indicating efficacy, Afatinib Dimaleate earned a rating of 2 on our team's safety scale. However, there is still data that confirms its basic safety."

Answered by AI

What end results is this experiment attempting to attain?

"The principal end-point of this clinical trial, evaluated over a 3 year period since registration, is Objective Response Rate (ORR). Secondary outcomes include Progression Free Survival (PFS) which is defined as the time from treatment start date to either disease progression or death occurring first. The Kaplan-Meier method will be used to estimate median PFS and Overall Survival (OS), with OS being assessed for each drug/step via the same technique. Disease progression evaluation shall occur at baseline and then every 2 cycles within the initial 26 cycle window; thereafter evaluations will happen every 3 cycles until patient's illness worsens according to criteria outlined by"

Answered by AI

Is this the inaugural effort of its kind?

"Since its inception in 2012, Afatinib Dimaleate has been the subject of 32 clinical studies conducted across 30 nations and 913 cities. Following a pioneering study sponsored by Boehringer Ingelheim involving 42 participants, it was approved as a phase 2 drug."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B)
2015. "Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04439136.
~4 spots leftby Apr 2025
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