- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02122172
Afatinib in Advanced Refractory Urothelial Cancer
Afatinib Dimaleate in Treating Patients With Advanced Refractory Urothelial Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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.
OUTLINE:
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
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Emory University Winship Cancer Institute
-
Contact:
- Bradley Carthon, MD
- Email: winshipcto@emory.edu
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago
-
Contact:
- Peter H. O'Donnell
- Phone Number: 773-702-7564
- Email: podonnel@medicine.bsd.uchicago.edu
-
Principal Investigator:
- Peter H. O'Donnell
-
Decatur, Illinois, United States, 62526
- Recruiting
- Decatur Memorial Hospital
-
Principal Investigator:
- James L. Wade
-
Contact:
- James L. Wade
- Phone Number: 217-876-6600
- Email: JLWADE3@sbcglobal.net
-
Evanston, Illinois, United States, 60201
- Completed
- Northshore University Health System
-
-
New York
-
New York, New York, United States, 10016
- Recruiting
- NYU Langone Health
-
Contact:
- Kaitlyn Francese
- Phone Number: 917-825-5820
- Email: Kaitlyn.Francese@nyulangone.org
-
Principal Investigator:
- Arjun Balar, MD
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- Recruiting
- University of North Carolina - Lineberger Comprehensive Cancer Center
-
Contact:
- Anly Thomas
- Phone Number: 919-962-8591
- Email: anly.thomas@email.unc.edu
-
Principal Investigator:
- Matthew Mitowsky, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients must have locally advanced or metastatic urothelial cancer that is not amenable to surgical treatment
- Patients must have histologically or cytologically confirmed urothelial tract carcinoma; patients with urothelial carcinoma of the bladder, upper tract, or urethra are eligible
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan for the evaluation of measurable disease (Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1])
- Patients must have evidence of disease progression prior to enrollment
- 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
- Patients may have received up to one line of prior systemic chemotherapy for recurrent/metastatic disease; if a platinum-based regimen was received both in the peri-operative setting and again in the metastatic setting, this will be considered 1 line of chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Absolute neutrophil count >= 1,000/mcL
- Platelets >= 100,000/mcL
- Hemoglobin >= 8.5g/dL
- Total bilirubin =< 1.5 institutional upper limit of normal (IULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X IULN
- Calculated creatinine clearance >= 30 mL/min by the modified Cockcroft and Gault Formula OR glomerular filtration rate >= 30 mL/min/body surface area (BSA) by Modification of Diet in Renal Disease or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
- Women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Patients must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients may not be receiving any other investigational agents
- Patients with untreated known brain metastases, or treated brain metastases that are clinically unstable
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- Women known to be pregnant
- Women who are breastfeeding and who are unwilling to stop breastfeeding prior to study entry
- Patients with known prior human immunodeficiency virus (HIV)-positive status on combination antiretroviral therapy are ineligible; known prior HIV-positive patients with CD4+ =< 500/mm^3 are ineligible (HIV testing is not required as part of this study)
- Pre-existing interstitial lung disease
- Inability to take oral medications
- Prior therapy with afatinib
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Correlative studies
Given PO
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: 3 months
|
Estimated using the Kaplan-Meier method.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (CR + PR)
Time Frame: Up to 3 years
|
Up to 3 years
|
|
Median progression-free survival (PFS ) time
Time Frame: Up to 3 years
|
Estimated using the Kaplan-Meier method.
|
Up to 3 years
|
Overall survival
Time Frame: Up to 3 years
|
Estimated using the Kaplan-Meier method.
|
Up to 3 years
|
EGFR expression status
Time Frame: Baseline
|
Relationship to 3-month PFS will be determined.
|
Baseline
|
HER2 expression status
Time Frame: Baseline
|
Relationship to 3-month PFS will be determined.
|
Baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of tumor micro ribonucleic acids (RNAs) like miR-200
Time Frame: Baseline
|
Relationship to 3-month PFS will be determined.
|
Baseline
|
Epithelial to mesenchymal transition states
Time Frame: Up to 3 years
|
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
|
Up to 28 days after last administration of trial drugs
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter O'Donnell, University of Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Urinary Bladder Diseases
- Disease Attributes
- Ureteral Diseases
- Urethral Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Recurrence
- Urinary Bladder Neoplasms
- Ureteral Neoplasms
- Urethral Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Afatinib
Other Study ID Numbers
- 13-0540
- P30CA014599 (U.S. NIH Grant/Contract)
- NCI-2014-00859 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- IRB13-0540
- 13-0540/ 1200.171 (Other Identifier: University of Chicago)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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