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NCT03410693 · ClinicalTrials.gov registry record · Phase 2
Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 175
- Enrollment target
NCT03410693 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 175 participants.
The verdict
NCT03410693, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 175 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Chemotherapy
- DRUG Rogaratinib (BAY1163877)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2018-05-31 |
| Est. Completion | 2020-10-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03410693
The ClinicalTrials.gov registry entry for NCT03410693 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Chemotherapy is the first listed.
NCT03410693 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03410693 about?
NCT03410693 is a clinical study titled "Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma". 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 pr...
What is the current status of trial NCT03410693?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 175 participants. The study started on 2018-05-31. Estimated completion is 2020-10-27.
What interventions are being tested in trial NCT03410693?
The interventions under investigation include: Chemotherapy (DRUG), Rogaratinib (BAY1163877) (DRUG).
Who is sponsoring clinical trial NCT03410693?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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