Ignite Creation Date:
2024-05-06 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03517956
Status:
COMPLETED
Last Update Posted:
2022-07-14
First Post:
2018-05-03
Brief Title:
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
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Multicenter Phase 1 Study to Evaluate the Safety Tolerability Pharmacokinetics and Maximum Tolerated Dose MTD andor Recommended Phase 2 Dose RP2D of the Combination of Rogaratinib and Copanlisib in Patients With FGFR-positive Locally Advanced or Metastatic Solid Tumors
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROCOCO
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-000419-26 | EUDRACT_NUMBER | None | None |