Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma

Completed · Phase 2/Phase 3

Conditions studied: Carcinoma, Transitional Cell

In brief

This is 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. The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.

Key facts

Study ID

NCT03410693

Run by

Bayer

People needed

175

Starts

2018-05-31

Expected to finish

2020-10-27

Last updated by the study team

2022-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Existence of archival or fresh biopsy for FGFR testing. Mandatory FGFR testing of patients will be performed prior to start of screening. The timing of the FGFR test is at the discretion of the investigator. Investigators should ensure all patients will be eligible in terms of disease status and lines of treatment.
• Documented urothelial carcinoma (transitional cell carcinoma) including urinary bladder, renal pelvis, ureters, urethra meeting all of the following criteria
• Histologically confirmed (Patients with mixed histologies are required to have a dominant transitional cell pattern.)
• Locally advanced (T4, 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 expression levels in archival or fresh tumor biopsy specimen quantified as outlined in the lab manual
• 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

You may not qualify if…

• 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 treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase inhibitors including rogaratinib or FGFR-specific antibodies) or with taxanes or vinflunine
• More than two prior lines of systemic anti-cancer therapy for urothelial carcinoma given for advanced unresectable/ metastatic disease
• Ongoing or previous anti-cancer treatment within 4 weeks before randomization.
• 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 before randomization
• 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)
• Current diagnosis of any retinal detachment, retinal pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion
• Any hemorrhage / bleeding event ≥ CTCAE v.4.03 Grade 3 within 4 weeks before randomization

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States
• University of Southern California — Los Angeles, California, United States
• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• Sansum Clinic — Santa Barbara, California, United States
• Rocky Mountain Cancer Centers — Littleton, Colorado, United States
• UF Cancer Center at Orlando Health — Orlando, Florida, United States
• University of Kansas Medical Center — Westwood, Kansas, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Compass Oncology — Tigard, Oregon, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Bon Secours St. Francis Hospital — Greenville, South Carolina, United States
• Texas Oncology-Denton South — Denton, Texas, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Summit Cancer Center — Spokane, Washington, United States
• Mid North Coast Cancer Institute — Coffs Harbour, New South Wales, Australia
• Northern Cancer Institute — St Leonards, New South Wales, Australia
• Macquarie University Hospital — Sydney, New South Wales, Australia
• Riverina Cancer Care Centre — Wagga Wagga, New South Wales, Australia
• Sydney Adventist Hospital — Wahroonga, New South Wales, Australia
• Pindara Private Hospital — Benowa, Queensland, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• Landesklinikum Krems — Krems, Austria
• Krankenhaus der Barmherzigen Brüder — Vienna, Austria
• Alaska Clinical Research Center, LLC — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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