Afatinib in Advanced Refractory Urothelial Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02122172|
Recruitment Status : Recruiting
First Posted : April 24, 2014
Last Update Posted : October 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Distal Urethral Cancer Proximal Urethral Cancer Recurrent Bladder Cancer Recurrent Urethral Cancer Stage III Bladder Cancer Stage III Urethral Cancer Stage IV Bladder Cancer Stage IV Urethral Cancer Ureter Cancer||Drug: afatinib dimaleate Other: laboratory biomarker analysis||Phase 2|
I. To determine the 3-month progression free survival (PFS) rate in metastatic urothelial cancer patients receiving afatinib (afatinib dimaleate) who have progressed despite prior platinum-based chemotherapy.
I. To determine the overall response rate (complete response [CR] + partial response [PR]), median progression free survival, and overall survival for the same treated population.
II. To determine whether tumor epidermal growth factor receptor (EGFR) and/or HER2 overexpression influences 3-month PFS in patients treated with afatinib.
Patients receive afatinib dimaleate orally (PO) once daily (QD) on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||95 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Afatinib Dimaleate in Treating Patients With Advanced Refractory Urothelial Cancer|
|Actual Study Start Date :||October 30, 2013|
|Estimated Primary Completion Date :||June 12, 2019|
|Estimated Study Completion Date :||June 12, 2019|
Experimental: Treatment (afatinib)
Patients receive afatinib dimaleate PO QD on days 1-42. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Drug: afatinib dimaleate
Other: laboratory biomarker analysis
- Progression-free survival (PFS) [ Time Frame: 3 months ]Estimated using the Kaplan-Meier method.
- Overall response rate (CR + PR) [ Time Frame: Up to 3 years ]
- Median progression-free survival (PFS ) time [ Time Frame: Up to 3 years ]Estimated using the Kaplan-Meier method.
- Overall survival [ Time Frame: Up to 3 years ]Estimated using the Kaplan-Meier method.
- EGFR expression status [ Time Frame: Baseline ]Relationship to 3-month PFS will be determined.
- HER2 expression status [ Time Frame: Baseline ]Relationship to 3-month PFS will be determined.
- Presence of tumor micro ribonucleic acids (RNAs) like miR-200 [ Time Frame: Baseline ]Relationship to 3-month PFS will be determined.
- Epithelial to mesenchymal transition states [ Time Frame: Up to 3 years ]
- Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 28 days after last administration of trial drugs ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02122172
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Peter H. O'Donnell 773-702-7564 firstname.lastname@example.org|
|Principal Investigator: Peter H. O'Donnell|
|Decatur Memorial Hospital||Recruiting|
|Decatur, Illinois, United States, 62526|
|Contact: James L. Wade 217-876-6600 JLWADE3@sbcglobal.net|
|Principal Investigator: James L. Wade|
|NorthShore University Health System||Completed|
|Evanston, Illinois, United States, 60201|
|Principal Investigator:||Peter O'Donnell||University of Chicago|