Ignite Creation Date:
2024-05-06 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03362723
Status:
COMPLETED
Last Update Posted:
2019-06-19
First Post:
2017-11-30
Brief Title:
A Study to Investigate the Bioequivalence or Relative Bioavailability of Three New Idasanutlin Tablet Variants Following Oral Administration in Participants With Solid Tumors
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Multi-Center Open-Label Clinical Pharmacology Study for Idasanutlin an MDM2 Antagonist With a Hybrid RandomizedSequential Single-Dose 4-Period Crossover Design to Investigate the Bioequivalence or Relative Bioavailability of Three New Idasanutlin Tablet Variants Following Oral Administration in Patients With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2019-06
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:
None
Brief Summary:
This multi-center open-label pharmacokinetic study will evaluate the bioequivalence BE or relative bioavailability rBA of three new idasanutlin-tablet variants compared to the reference tablet formulation following oral administration of a 300 milligrams mg dose in participants with solid tumors for whom no further treatment options are available Following the four administrations of idasanutlin in the BErBA cycle of the study Cycle 1 participants who have no clinically defined progressive disease and who recover from any prior treatment toxicity to Grade less than or equal to 1 may enter the optional treatment extension phase This extension phase will continue for additional 28-day cycles or until disease progression or unacceptable toxicity is observed
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