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Protocol NumberBAY 1163877 / 17403
NCT Number(ClinicalTrials.gov Identfier)NCT03410693

2018-04-30 - 2022-10-31

Phase II/III

Terminated6

ICD-10C67.9

Malignant neoplasm of bladder, unspecified

ICD-10C67

Malignant neoplasm of bladder

ICD-9189.9

Malignant neoplasm of urinary organ, site unspecified

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

  • Trial Applicant

    BAYER TAIWAN COMPANY LTD.

  • Sponsor

    Bayer

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Jian-Ri Li Division of Urology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wen-Pin Su Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator Hsiao-Jen Chung Division of Urology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chao-Hsiang Chang Division of Urology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chao-Hsiang Chang 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

None

Principal Investigator See-Tong Pang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Taiwan National PI

馮思中

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

4 Terminated

Audit

None

Principal Investigator Yu-Chieh Tsai Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Condition/Disease

FGFR-positive Locally Advanced or Metastatic Urothelial Carcinoma Who Have Received Prior Platinum-containing Chemotherapy

Objectives

Primary objective:  To demonstrate the superiority of rogaratinib over chemotherapy in terms of prolonging overall survival of urothelial carcinoma patients with FGFR positive tumors. Secondary objectives:  To evaluate additional efficacy including the following variables o progression-free survival (PFS) o objective response rate (ORR) o disease control rate (DCR) o duration of response (DOR)  To evaluate the safety of rogaratinib (adverse events) Tertiary objectives:  Patient-reported outcome (PRO)  Evaluate biomarkers to investigate the drug (i.e. mode-of-action-related effect and/or safety) and/or the pathomechanism of the disease  Pharmacokinetics The objective for the Phase 2 part of the study is to demonstrate the efficacy of rogaratinib over chemotherapy in terms of objective response rate of urothelial carcinoma patients with FGFR positive tumors

Test Drug

BAY 1163877

Active Ingredient

Rogaratinib

Dosage Form

Tablet

Dosage

200

Endpoints

Primary Outcome Measures :
Objective response rate (ORR) [ Time Frame: Up to 45 months ]
Defined as the percentage of patients with complete response (CR) or partial response (PR). Patients for whom overall best response is not CR or PR, as well as patients without any post-baseline tumor assessment will be considered non-responders.


Secondary Outcome Measures :
Progression-free survival (PFS) [ Time Frame: Up to 45 months ]
Defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment) or death due to any cause, if death occurs before progression is documented. For patients without documented radiological or clinical progression or death at the time of analysis, PFS will be censored at the last actual visit date of tumor evaluation.

Disease-control rate (DCR) [ Time Frame: Up to 45 months ]
Defined as the percentage of patients, whose overall best response was not progressive disease [PD] (i.e. CR, PR, Stable Disease [SD] or Non CR/Non PD). Tumor assessments with SD as response, that is performed prematurely after randomization of the patient (i.e. substantially earlier than the first planned radiological tumor assessment at 6 weeks), will not be taken into account.

Duration of response (DOR) [ Time Frame: Up to 45 months ]
Defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. patients with a CR or PR.

Incidence of Adverse Events as a measure of safety and tolerability [ Time Frame: Up to 45 months ]

Inclution Criteria

1. Ability to understand and signing of the written patient
information/informed consent form (PI/ICF) for FGFR testing 
2. Existence of archival or fresh biopsy for FGFR testing 
3. FGFR testing of patients will be performed at the investigators’
discretion up to a max. of 90 days prior to start of screening
(signing of informed consent for study treatment eligibility).
Investigators should ensure all patients will be eligible in terms
of disease status and lines of treatment within this timeframe. If
the patient is positive for FGFR 1 and/or 3 and is unable to start
screening by 90 days after FGFR testing, the patient may still be
considered for screening after discussion with the sponsor’s
designated medical representative and approval by the sponsor.

4. Male or female patients ≥ 18 years of age (at least age of legal
maturity) 
5. Documented urothelial carcinoma (transitional cell carcinoma)
including urinary bladder, renal pelvis, ureters, urethra, meeting
all of the following criteria
o Histologically or cytologically confirmed
 Patients with mixed histologies are required to
have a dominant transitional cell pattern.
o 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).

6. ECOG Performance Status of 0 or 1
 
7. 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.
8. 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

9. Ability to understand and signing of the written PI/ICF for study
treatment eligibility. Signed informed consent form must be
available before any study-specific procedure for the respective
study parts may begin.

10. 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

11. Adequate laboratory and organ function:
o Absolute neutrophil count (ANC) ≥ 1,500/mm3
o Platelet count ≥ 100,000/mm3
o Hemoglobin ≥ 9.0 g/dL (without transfusion or
erythropoietin within 4 weeks before randomization)
o Total bilirubin ≤ 1.5 times the upper limit of normal
(ULN). Known Gilbert syndrome is allowed if total
bilirubin is ≤ 3 x ULN.
o Alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for
patients with liver involvement of their cancer)
o Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for
patients with liver and bone involvement of their cancer)
o Lipase < 2 x ULN
o Glomerular filtration rate (GFR) ≥ 30 mL/min/1.73 m2
according to Modification of Diet in Renal Disease
(MDRD) abbreviated formula.
o International normalized ratio (INR) ≤ 1.5  ULN, and
partial thromboplastin time (PTT) or activated PTT
(aPTT) ≤ 1.5  ULN. Patients being treated with
anticoagulant, e.g. warfarin or heparin, will be allowed
to participate provided no prior evidence of an
underlying abnormality in these parameters exists. Close
monitoring of at least weekly evaluations will be
performed until INR is stable based on a pre-dose
measurement as defined by the local standard of care.
12. Women of childbearing potential (WOCBP) and fertile men
must agree to use adequate contraception when sexually active
from signing of the ICF for study treatment eligibility until at
least 12 weeks after the last study drug administration. The
investigator or a designated associate is requested to advise the
patient how to achieve highly effective birth control. Highly
effective (failure rate of less than 1% per year) contraception
methods include:
o Combined (estrogen and progesterone containing: oral,
intravaginal, transdermal) and progesterone-only (oral,
injectable, implantable) hormonal contraception
associated with inhibition of ovulation.
o Intrauterine device (IUD) or intrauterine hormonereleasing system (IUS).
o Bilateral tubal occlusion or vasectomized partner
(provided that partner is the sole sexual partner and has
received medical assessment of the surgical success).
o Sexual abstinence (reliability to be evaluated in relation
to the duration of the clinical trial and the preferred and
usual lifestyle of the patient).
 Periodic abstinence (e.g., calendar, ovulation,
symptothermal, or postovulation methods) and
withdrawal are not acceptable methods of
contraception.
Male patients with a female partner of childbearing potential
must use a condom and ensure that an additional form of
contraception is also used during treatment and until 12 weeks
after last study drug administration.
13. Negative serum pregnancy test in women of childbearing
potential (performed within 7 days before randomization).
Negative results must be available prior to study drug
administration.

Exclusion Criteria

1. Previous or concurrent cancer except
o cervical carcinoma in situ
o treated basal-cell or squamous cell skin carcinoma
o any cancer curatively treated > 3 years before
randomization
o curatively treated incidental prostate cancer (T1/T2a)

2. Symptomatic metastatic brain or meningeal tumors unless the
patient is > 6 months from definitive therapy, has no
radiological evidence of tumor growth and is clinically stable
with respect to the tumor at randomization. Also the patient
must not be undergoing acute steroid therapy or taper (chronic
steroid therapy is acceptable provided that the dose is stable for
one month prior to and following screening radiographic
studies).

3. Known human immunodeficiency virus (HIV) infection 
4. Renal dialysis

5. Any malabsorption condition 
6. Breast-feeding 
7. 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
8. More than two prior lines of systemic anti-cancer therapy for
urothelial carcinoma 
9. Ongoing or previous anti-cancer treatment within 4 weeks
before randomization.
o Patients who have received prior treatment with antiCTLA-4 may be enrolled provided at least 5 half-lives
(approximately 75 days) have elapsed before
randomization.
o Prior cancer vaccines and cellular immunotherapy are
permitted.
o Previous radiotherapy is acceptable under the following
conditions:
 Therapeutic radiotherapy ≥ 3 weeks before the
baseline tumor scan.
 Palliative radiotherapy for bone metastases or soft
tissue lesions is allowed and should be completed
>7 days prior to baseline tumor scan.
 Lesions at the site of previous radiotherapy should
have evidence of progressive disease if this is the
only site of disease.
Anti-cancer therapy is defined as any agent or combination of
agents with clinically proven anti-tumor activity administered
by any route with the purpose of affecting the malignancy,
either directly or indirectly, including palliative and therapeutic
endpoints.

10. Use of strong inhibitors and inducers of CYP3A4 (see
Appendix 16.1) should have been stopped 2 weeks before
randomization.

11. Concomitant therapies that are known to increase serum
calcium or phosphate levels and cannot be discontinued or
switched to a different medication before randomization

12. Substance abuse, medical, psychological or social conditions
that may interfere with the patient’s participation in the study or
evaluation of the study results

13. Major surgery, or significant trauma within 4 weeks before
randomization (central line surgery is not considered major
surgery)
14. 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

15. History or current condition of an uncontrolled cardiovascular
disease including any of the following conditions:
o Congestive heart failure (CHF) NYHA > Class 2
o Unstable angina (symptoms of angina at rest) or new-onset
angina (within last 3 months before randomization)
o Myocardial infarction (MI) within past 6 months before
randomization
o Unstable cardiac arrhythmias requiring anti-arrhythmic
therapy. Patients with arrhythmia under control with antiarrhythmic therapy such as beta-blockers or digoxin are
eligible

16. 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

17. Current evidence of endocrine alteration of calcium phosphate
homeostasis (e.g. parathyroid disorder, history of
parathyroidectomy, tumor lysis, tumoral calcinosis,
paraneoplastic hypercalcemia)

18. Current diagnosis of any retinal detachment, retinal pigment
epithelial detachment (RPED), serous retinopathy or retinal vein
occlusion

19. Active infection with hepatitis B or C, requiring treatment

20. Active infections (≥ CTCAE v.4.03 Grade 3) 
21. Evidence or history of bleeding diathesis or coagulopathy 
22. Any hemorrhage / bleeding event ≥ CTCAE v.4.03 Grade 3
within 4 weeks before randomization 
23. Seizure disorder requiring therapy 
24. Serious, non-healing wound, ulcer or bone fracture 
25. Any condition that is unstable or could jeopardize the safety of
the patient and his/her compliance in the study
26. Inability to swallow oral medications

27. Known hypersensitivity to any of the study drugs, study drug
classes, or excipients in the formulation 
28. Previous assignment to study treatment during this study 
29. Investigational drug treatment outside of this study during or
within 4 weeks before randomization. 
30. Close affiliation with the investigational site; e.g. a close
relative of the investigator, dependent person (e.g. employee or
student of the investigational site)

The Estimated Number of Participants

  • Taiwan

    14 participants

  • Global

    175 participants

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