An international, multicenter, Phase 1b/2 study of rogaratinib (BAY 1163877) in combination with atezolizumab as first-line treatment in cisplatin-ineligible patients with FGFR-positive locally advanced or metastatic urothelial carcinoma - Phase 1b/2 study of pan FGFR inhibitor

Bayer AG0 sites190 target enrollmentFebruary 8, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: FGFR-positive locally advanced or metastatic urothelial carcinoma
Sponsor: Bayer AG
Enrollment: 190
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

February 8, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Male/female patients \= 18 years of age (at least age of legal maturity)
•Urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra, meeting all of the following criteria:
•o Histologically confirmed.
•o Patients with mixed histology are required to have a dominant transitional cell pattern
•o Locally advanced (T4, any N; or any T, N2\-3\) or metastatic disease (any T, any N and M1\)
•Note: Locally advanced bladder cancer must be unresectable i.e. invading the pelvic or abdominal wall (stage T4b) or presenting with bulky nodal disease (N2\-3\)
•High FGFR1 or 3 mRNA expression levels (RNAscope score of 3\+ or 4\+; measurement is part of this protocol) in archival or fresh tumor biopsy specimen
•Measurable disease according to RECIST v1\.1
•ECOG PS 0 or 1
•Adequate hematological and end organ function

•Inability to swallow oral medications
•Any malabsorption condition
•Current diagnosis of retinal disorders including retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion
•Previous or concurrent cancer except
•o cervical carcinoma in situ
•o treated basal\-cell carcinoma or squamous cell skin cancer
•o localized prostate cancer treated with curative intent and absence of prostate\-specific antigen (PSA) relapse or incidental prostate cancer (T1/T2a, Gleason score \= 6 and PSA \< 10 ng/mL undergoing active surveillance and treatment\-naïve)
•o any other cancer curatively treated \> 3 years before the first study drug administration
•Investigational drug treatment outside of this study during or within 4 weeks before the first study drug administration
•Ongoing or previous treatment with anti\-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFR\-specific antibodies)