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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2022
• Main ID: NCT03410693
• Date of registration: 19/01/2018
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma FORT-1
• Scientific title: A Randomized, Open Label, Multicenter Phase 2/3 Study to Evaluate the Efficacy and Safety of Rogaratinib (BAY1163877) Compared to Chemotherapy in Patients With FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy
• Date of first enrolment: May 31, 2018
• Target sample size: 175
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03410693
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Portugal, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

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 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Carcinoma, Transitional Cell

Intervention(s)

Drug: Chemotherapy

Drug: Rogaratinib (BAY1163877)

Primary Outcome(s)

Objective Response Rate (ORR) - Central Assessment [Time Frame: From start of treatment up to end of active follow-up, approximately 29 months]

Secondary Outcome(s)

Duration of Response (DOR) - Central Assessment [Time Frame: From start of treatment till end of active follow-up, approximately 29 months]

Disease-control Rate (DCR) - Central Assessment [Time Frame: From start of treatment till end of active follow-up, approximately 29 months]

Progression-free Survival (PFS) - Central Assessment [Time Frame: From start of treatment till end of active follow-up, approximately 29 months]

Number of Participants With Treatment Emergent Adverse Events [Time Frame: From start of treatment up to 30 days after the last administration of study treatment, approximately 29 months]

Secondary ID(s)

17403

2016-004340-11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/12/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03410693