Status:
COMPLETED
Derazantinib and Atezolizumab in Patients With Urothelial Cancer
Lead Sponsor:
Basilea Pharmaceutica
Conditions:
Urothelial Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study was to evaluate efficacy of derazantinib monotherapy or derazantinib-atezolizumab in combination in patients with advanced urothelial cancer harboring fibroblast growth facto...
Detailed Description
The study comprised five open-label substudies (1-5) in patients with advanced urothelial cancer harboring FGFR GA (with the exception of substudy 2 which did not require a FGFR GA) who were treated b...
Eligibility Criteria
Inclusion
- Histologically-confirmed transitional cell carcinoma of the urothelium of the upper or lower urinary tract
- Recurrent or progressing stage IV disease, or surgically unresectable, recurrent or progressing disease
- Documented central FGFR genetic aberration (FGFR1, FGFR2, or FGFR3 mutations / short variants and rearrangements / fusions) (Note; Substudy 2 started with patients requiring an FGFR GA, but this requirement was removed from the protocol later on)
- Measurable disease, as defined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- Adequate organ functions as indicated by Screening visit local laboratory values
Exclusion
- Receipt of prior cancer treatment within specific interval periods
- Concurrent evidence of any clinically significant corneal or retinal disorder
- History of clinically significant cardiac disorders
- Known CNS metastases
- Concurrent uncontrolled or active infection with human immunodeficiency virus
- Active hepatitis B or chronic hepatitis B without current antiviral therapy
- Active hepatitis C
- Active tuberculosis
- Severe bacterial, fungal, viral and/or parasitic infections on therapeutic oral or IV medication at the time of first dose of study drug administration
Key Trial Info
Start Date :
August 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2022
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04045613
Start Date
August 2 2019
End Date
October 4 2022
Last Update
October 13 2023
Active Locations (66)
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1
CTCA Clinical Research Inc., Atlanta
Newnan, Georgia, United States, 30265
2
Englander Institute Weill Cornell Medicine
New York, New York, United States, 10021
3
New York Cancer and Blood Specialists
Port Jefferson Station, New York, United States, 11776
4
University of Texas Southwestern Medical Center (UTSWMC)
Dallas, Texas, United States, 75390-8852