Ignite Creation Date:
2024-05-05 @ 11:59 PM
Last Modification Date:
2024-10-26 @ 10:42 AM
Study NCT ID:
NCT01462175
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-10-27
Brief Title:
A First-In-Human Study of RO5503781 in Participants With Advanced Malignancies Except Leukemia
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Multi-center Open Label First in Human Phase I Dose Escalation Study of Single Agent RO5503781 a Small Molecule MDM2 Antagonist Administered Orally in Patients With Advanced Malignancies Except Leukemia
Status:
COMPLETED
Status Verified Date:
2016-11
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 multicenter open label dose-escalating study will evaluate the safety pharmacokinetics pharmacodynamics and efficacy of RO5503781 administered once daily QD or once weekly QW in participants with advanced malignancies except leukemia Participants will receive multiple escalating oral doses in two different dosing schedules Sch until disease progression or unacceptable toxicity occurs
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2011-002767-15 | EUDRACT_NUMBER | None | None |