NL-OMON46559CompletedPhase 2
A randomized, open label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy - Rogaratinib vs chemotherapy in patients with urothelial carcinoma
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 41
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- Existence of archival or fresh biopsy for FGFR testing
- •- FGFR testing of patients will be performed at the investigators* discretion up to a max. of 90 days prior to start of screening. Investigators should ensure all patients will be eligible in terms of disease status and lines of treatment within this timeframe.
- •- Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria
- •-- Histologically or cytologically confirmed (patients with mixed histologies are required to have a dominant transitional cell pattern.)
- •-- Locally advanced (T4b, any N; or any T, N 2*3) or metastatic disease (any T, any N and M1). 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).
- •- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 or 1
- •- Disease progression during or following treatment with at least one platinum-containing regimen (patients should have been treated for at least 2 cycles). In patients who received prior adjuvant/neoadjuvant platinum-containing chemotherapy, progression had to occur within 12
- •months of treatment.
- •- High FGFR1 or 3 mRNA (Messenger ribonucleic acid) expression levels (RNAscope score of 3+ or 4+; measurement is part of this protocol) in archival or fresh Tumor biopsy specimen
- •- At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v.1.1) in contrast enhanced (unless contraindicated) CT or MRI
Exclusion Criteria
- •- Previous or concurrent cancer except
- •-- cervical carcinoma in situ
- •-- treated basal-cell or squamous cell skin carcinoma
- •-- any cancer curatively treated > 3 years before randomization
- •-- Curatively treated incidental prostate cancer (T1/T2a)
- •- Ongoing or previous anti-cancer treatment within 4 weeks before randomization.
- •- More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma
- •- Ongoing or previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFRspecific antibodies) or with taxanes or vinflunine
- •- Unresolved toxicity higher than National Cancer Institute*s Common Terminology Criteria for Adverse Events, version 4.03 (CTCAE v.4.03) Grade 1 attributed to any prior therapy/procedure excluding alopecia, anemia and/or hypothyroidism
- •- History or current condition of an uncontrolled cardiovascular disease including any of the following conditions:
- •-- Congestive heart failure (CHF) NYHA (New York Heart Association) > Class 2
- •-- Unstable angina (symptoms of angina at rest) or new-onset angina (within last 3 months before randomization)
- •-- Myocardial infarction (MI) within past 6 months beforerandomization
- •-- Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with arrhythmia under control with anti-arrhythmic therapy such as beta-blockers or digoxin are eligible.
- •- Arterial or venous thrombotic events or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before randomization
- •- Current evidence of endocrine alteration of calcium Phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)
- •- Any hemorrhage / bleeding event * CTCAE v.4.03 Grade 3 within 4 weeks before randomization
- •- Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion
Investigators
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