← Back to Search

Tyrosine Kinase Inhibitor

Afatinib for Bladder Cancer

Phase 2

Recruiting

Led By Peter O'Donnell

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Patients must have histologically or cytologically confirmed urothelial tract carcinoma; patients with urothelial carcinoma of the bladder, upper tract, or urethra are eligible

All patients must have received a prior platinum-based chemotherapy regimen for treatment of urothelial cancer and must now be considered refractory to platinum-based chemotherapy; patients may have received the platinum-containing regimen either in the peri-operative or metastatic setting

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial studies a drug for patients with urothelial cancer that has grown after first-line chemotherapy. The drug may work by turning off the growth receptors on the cancer cells.

Who is the study for?

This trial is for adults with advanced urothelial cancer that surgery can't remove and has worsened after first-line chemo. They must have had platinum-based chemo, measurable disease, good organ function, not be pregnant or breastfeeding, agree to use contraception, and not have certain health issues like brain metastases or severe lung disease.Check my eligibility

What is being tested?

The study tests afatinib dimaleate's effectiveness on patients with urothelial cancer resistant to standard chemotherapy. It targets EGF and HER2 receptors in cancer cells to potentially slow growth or cause cell death. Participants' response to the drug is monitored through lab biomarker analysis.See study design

What are the potential side effects?

Afatinib may cause diarrhea, rash, mouth sores, nail inflammation, fatigue, decreased appetite and weight loss. Less common but serious side effects include lung problems (like trouble breathing), liver issues (like hepatitis), heart problems (including heart failure), eye inflammation and skin reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

My cancer is confirmed to be urothelial carcinoma.

Select...

I have urothelial cancer and platinum-based treatments no longer work for me.

Select...

My bladder cancer has spread and cannot be removed with surgery.

Select...

I have a tumor that can be measured with a scan.

Select...

My condition has worsened before joining this study.

Select...

My kidney function is sufficient, as measured by creatinine clearance or filtration rate.

Select...

I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Secondary outcome measures

EGFR expression status

HER2 expression status

Median progression-free survival (PFS ) time

+2 more

Other outcome measures

Epithelial to mesenchymal transition states

Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

15S RNA

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (afatinib)Experimental Treatment2 Interventions

Patients receive afatinib dimaleate PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,926,038 Total Patients Enrolled

21 Trials studying Urethral Cancer

2,171 Patients Enrolled for Urethral Cancer

University of ChicagoLead Sponsor

1,004 Previous Clinical Trials

819,682 Total Patients Enrolled

Peter O'DonnellPrincipal InvestigatorUniversity of Chicago

1 Previous Clinical Trials

1,900 Total Patients Enrolled

Media Library

Afatinib dimaleate (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02122172 — Phase 2

Urethral Cancer Research Study Groups: Treatment (afatinib)

Urethral Cancer Clinical Trial 2023: Afatinib dimaleate Highlights & Side Effects. Trial Name: NCT02122172 — Phase 2

Afatinib dimaleate (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02122172 — Phase 2

Frequently Asked Questions

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

Has afatinib dimaleate been explored in any other scientific investigations?

"Currently, there are 32 clinical trials that explore the efficacy and safety of afatinib dimaleate. Two of them have reached Phase 3 on their journey to getting approved for medical use. The majority of these tests take place in Nagoya-shi, Aichi; however, this medication is being tested across 2060 other sites worldwide."

Answered by AI

What is the total number of participants in this experiment?

"A total of 95 eligible patients are required to partake in this research endeavour. People looking to join the trial may do so from Emory University Winship Cancer Institute situated in Atlanta, Georgia and NYU Langone Health located in New york City."

Answered by AI

Has the FDA given its blessing to afatinib dimaleate?

"Afatinib dimaleate's safety has been partially established, leading to the drug receiving a score of 2. Clinical data on its efficacy is yet to be collected."

Answered by AI

Are there multiple locations in this state hosting the clinical trial?

"Emory University Winship Cancer Institute, NYU Langone Health and Decatur Memorial Hospital serve as the primary trial sites for this clinical research. In addition to these 3 hubs, there are 5 ancillary locations participating in the study."

Answered by AI

Is this a pioneering medical trial?

"At present, there are 32 ongoing clinical trials for afatinib dimaleate in 913 cities and 30 nations. The initial research began in 2012 when Boehringer Ingelheim conducted a Phase 2 study that included 42 patients. Since then, 886 other studies have concluded successfully."

Answered by AI

Are there any vacancies for individuals to participate in this research?

"Affirmative. The clinical trial is actively seeking participants, as detailed on the clinicaltrials.gov website which shows that this study was first added to their database on October 30th 2013 and last updated September 24th 2021 for a total of 95 enrollees at 5 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Afatinib in Advanced Refractory Urothelial Cancer

2013. "Afatinib in Advanced Refractory Urothelial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02122172.

All > North Carolina