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NCT03517956 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03517956 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 16 participants.
The verdict
NCT03517956, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The primary objective of this study is to determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) and efficacy of rogaratinib in combination with copanlisib in patients with locally advanced or metastatic solid tumors that are mRNA-positive for at least one FGFR1-4 subtype. The secondary objectives of this study are to characterize the pharmacokinetics (PK) of rogaratinib and copanlisib alone and in combination, and to assess the anti-tumor efficacy of rogaratinib in combination with copanlisib for locally advanced or metastatic solid tumors that are mRNA-positive for at least one FGFR1-4 subtype.
Interventions
- DRUG Rogaratinib (BAY1163877)
- DRUG Copanlisib (BAY80-6946)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-07-25 |
| Est. Completion | 2021-02-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03517956
The ClinicalTrials.gov registry entry for NCT03517956 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 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 Rogaratinib (BAY1163877) is the first listed.
NCT03517956 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03517956 about?
NCT03517956 is a clinical study titled "Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors". The primary objective of this study is to determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) and efficacy of rogaratinib in combination with copanlisib in patients with locally advanced or metastatic solid tumors that are mRNA-positive for at least on...
What is the current status of trial NCT03517956?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2018-07-25. Estimated completion is 2021-02-01.
What interventions are being tested in trial NCT03517956?
The interventions under investigation include: Rogaratinib (BAY1163877) (DRUG), Copanlisib (BAY80-6946) (DRUG).
Who is sponsoring clinical trial NCT03517956?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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