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NCT01976741 · ClinicalTrials.gov registry record · Phase 1
Dose Escalation Pan-FGFR (Fibroblast Growth Factor Receptor) Inhibitor (Rogaratinib)
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 168
- Enrollment target
NCT01976741: Completed Phase 1 study, sponsored by Bayer.
NCT01976741 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 168 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (180% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01976741, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 168 participants
- Enrollment target
Study Summary
* This was the first study where BAY1163877 was given to humans. Impact of the study was to evaluate if patients with advanced solid cancers show advanced clinical benefit under the treatment with the pan FGFR inhibitor. Patients (all comers) received the study drug treatment in a dose-escalation scheme (no placebo group) to determine the safety, tolerability and maximum tolerated dose (MTD) of BAY1163877. The relative bioavailability of liquid service formulation and tablets was determined. * After the MTD was defined patients with solid tumors (all comers), lung cancer (lung adenocarcinoma \& squamous non-small cell lung cancer), head and neck cancer or bladder cancer was enrolled according to their FGFR expression profile (biomarker stratification). * The study also assessed the pharmacokinetics, biomarker status, pharmacodynamic parameters and tumor response of BAY1163877. * BAY1163877 was given twice daily as oral application. Treatment was stopped if the tumor continued to grow, if side effects, which the patient cannot tolerate, occurred or if the patient decided to exit treatment.
Primary Outcome
The MTD was defined as maximum dose at which the incidence of Dose Limiting Toxicities (DLTs) during Cycle 1 is below 20%. DLT was defined as any of the pre-defined adverse events occurring during Cycle 1 of a dose level and regarded by the investigators and/or sponsor to be related to the investigational drug. BID=twice daily.
Interventions
- DRUG Rogaratinib (BAY1163877) oral solution
- DRUG Rogaratinib (BAY1163877) oral tablet
- DRUG Rogaratinib (BAY1163877) 800 mg BID
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2013-12-30 |
| Est. Completion | 2020-01-09 |
| Phase | Phase 1 |
What the finished NCT01976741 record still lists
NCT01976741 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (180% higher).
The record links to 0 conditions, and to 3 interventions - of which Rogaratinib (BAY1163877) oral solution is the first listed.
NCT01976741 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01976741 about?
NCT01976741 is a clinical study titled "Dose Escalation Pan-FGFR (Fibroblast Growth Factor Receptor) Inhibitor (Rogaratinib)". * This was the first study where BAY1163877 was given to humans. Impact of the study was to evaluate if patients with advanced solid cancers show advanced clinical benefit under the treatment with the pan FGFR inhibitor. Patients (all comers) received the study drug treatment in a dose-escalation sc...
What is the current status of trial NCT01976741?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 168 participants. The study started on 2013-12-30. Estimated completion is 2020-01-09.
What interventions are being tested in trial NCT01976741?
The interventions under investigation include: Rogaratinib (BAY1163877) oral solution (DRUG), Rogaratinib (BAY1163877) oral tablet (DRUG), Rogaratinib (BAY1163877) 800 mg BID (DRUG).
Who is sponsoring clinical trial NCT01976741?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01976741's enrollment target sits among peer trials
168 326th of 2000 higher than 1,671 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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