A Study of Experimental Medicine Rogaratinib (BAY1163877) vs Chemotherapy For Urothelial Carcinoma (cancer of the urinary tract)

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: FGFR-positive cancer, locally advanced or metastatic, locally advanced or metastatic cancer, locally advanced or metastatic urothelial carcinoma
Type: Drug study, Phase [/2/,/ /3/]
Target:
12 Participants
Investigator:
Description
The purpose of this study is to investigate if the study drug rogaratinib (also known as BAY 1163877) is safe. The study team hope to learn if it works better to reduce the size of your tumor when compared to chemotherapy.

The test drug rogaratinib, also known as an FGFR inhibitor, is not approved yet for sale in any country. Investigational means that it has not been approved by the FDA and is only available to people who are in research studies. The other drug that you will be taking, docetaxel or paclitaxel, has already been approved for the treatment of locally advanced or metastatic urothelial cancer.

The study drug is an investigational drug which belongs to a new class of medication called tyrosine kinase inhibitors.

A tyrosine kinase inhibitor targets certain key structures called proteins in or on the surface of your cells. They are needed for the survival of the cancer cells. Rogaratinib targets a class of tyrosine kinases called fibroblast growth factor receptors (FGFR). Therefore, these drugs work by stopping the cell growth of your cancer cells in a specific way and may even decrease the size of your tumor.

In order to compare the test drug to existing therapies, some patients will receive a chemotherapy treatment instead of rogaratinib. The chemotherapy treatment that will be used will be either paclitaxel or docetaxel; depending on your study doctor’s choice.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

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 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)
  • 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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
There is not a pre-determined length of time for your participation. You will continue to receive treatment as long as you are receiving clinical benefit and your disease doesn’t progress.
Recruitment period
From June 8, 2018
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Research Topic
Conditions:
  • Carcinoma, Transitional Cell

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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