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Tyrosine Kinase Inhibitor

Afatinib for Advanced Skin Cancer

Phase 2

Recruiting

Led By Zeynep Eroglu, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 1 measurable lesion - either per RECIST 1.1 criteria, or for patients with externally visible cuSCC lesion(s) not measurable on imaging, at least one lesion ≥1 cm in longer diameter, amenable to digital photography with bi-dimensional measurements

Histologic diagnosis of invasive cutaneous squamous cell carcinoma, that is deemed not appropriate for further surgical intervention and/or radiation therapy. Participants may have either locally advanced or metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial will test if Afatinib can help treat people with advanced cSCC.

Who is the study for?

Adults with advanced cutaneous squamous cell carcinoma (cSCC) not suitable for surgery/radiation, who've had prior immunotherapy if eligible. Must have good organ function and performance status, a measurable lesion, and be at least 2 weeks post any major treatment or surgery. Those with treated brain metastases can join; however, those with severe liver issues, mixed cancer types, untreated HIV/HCV or pregnancy are excluded.Check my eligibility

What is being tested?

The trial is testing the effectiveness of Afatinib 40 MG in treating advanced cSCC. Participants will receive this medication to see if it improves their condition compared to previous treatments they may have received.See study design

What are the potential side effects?

While specific side effects for this trial aren't listed here, common ones associated with Afatinib include diarrhea, skin rashes and reactions, nail inflammation, mouth sores and decreased appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have at least one cancer lesion that can be measured or seen and photographed.

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I have a type of skin cancer that can't be treated with surgery or radiation.

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I can take care of myself but might not be able to do heavy physical work.

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I have a weakened immune system, including autoimmune diseases or organ transplants.

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I am 18 years old or older.

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My blood counts and organ functions are within the required ranges.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Overall Response Rate

Secondary outcome measures

Overall survival

Progression free survival

Treatment-related adverse events

Trial Design

1Treatment groups

Experimental Treatment

Group I: Afatinib InterventionExperimental Treatment1 Intervention

Participants will receive afatinib 40 mg once a day. Each cycle is 4 weeks. They will have CT imaging (and/or digital photography) done at baseline and every 8 weeks while on treatment. Participants will have a baseline and on-treatment (at 4 weeks) tumor biopsy, and a biopsy at disease progression if feasible. Patients may remain on treatment as long as they are deriving clinical benefit, until disease progression or intolerable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Afatinib 40 MG

2022

Completed Phase 2

~10

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimIndustry Sponsor

2,507 Previous Clinical Trials

11,340,882 Total Patients Enrolled

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,470 Total Patients Enrolled

Zeynep Eroglu, MDPrincipal InvestigatorMoffitt Cancer Center

3 Previous Clinical Trials

109 Total Patients Enrolled

Media Library

Afatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05070403 — Phase 2

Squamous Cell Carcinoma Research Study Groups: Afatinib Intervention

Squamous Cell Carcinoma Clinical Trial 2023: Afatinib Highlights & Side Effects. Trial Name: NCT05070403 — Phase 2

Afatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05070403 — Phase 2

Frequently Asked Questions

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

How many individuals have been included in this research study so far?

"Yes, as provided by clinicaltrials.gov this trial is currently accepting applicants. The study was first launched on September 24th 2021 and has been recently updated on July 27th 2022. A total of 25 patients are being recruited from one location."

Answered by AI

Has the Federal Drug Administration authorized Afatinib 40 MG for public use?

"There is evidence that Afatinib 40 MG can be used safely, so Power awarded it a 2 on their safety scale. No clinical data exists to back its efficacy as of yet."

Answered by AI

To what extent has Afatinib 40 MG been explored in prior clinical research?

"As of the present moment, 32 clinical trials pertaining to Afatinib 40 MG are ongoing. Of those actively running studies, two have reached Phase 3. Although many of these trails originate in Nagoya-shi, Aichi, there are 2060 locations across the globe that are testing this specific therapeutic agent."

Answered by AI

Are there still opportunities for participants to join this research endeavor?

"According to clinicaltrials.gov, this research study is actively recruiting participants with an initial post date of September 24th 2021 and the latest update being July 27th 2022."

Answered by AI

Has this experiment been conducted before or is it a pioneering venture?

"Currently, 32 ongoing Afatinib 40 MG trials are running in 913 cities and 30 countries. This drug's first clinical trial was backed by Boehringer Ingelheim in 2012 with 42 participants who completed the Phase 2 approval stage. Since this initial study, 97 additional trials have been conducted for Afatinib 40 MG."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma

2021. "Study of Afatinib in Advanced Cutaneous Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05070403.

All > Squamous Cell Carcinoma