Ignite Creation Date:
2024-05-06 @ 12:51 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01677780
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2012-08-30
Brief Title:
An Extension Study of RO5045337 in Participants Participating in Previous Roche-sponsored Cancer Studies
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Multi-Center Open-Label Extension Study of RO5045337 MDM2 Antagonist Administered Orally in Patients Treated With RO5045337 on Previous Roche-Sponsored Phase 1 Cancer Studies
Status:
COMPLETED
Status Verified Date:
2017-07
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:
None
Brief Summary:
This open-label extension study is designed to provide continuing treatment with RO5045337 to participants who have completed parent studies NO21279 NCT00623870 NO21280 NCT00559533 NP25299 NCT01164033 NP28021 NCT01605526 or NP28023 NCT01635296 Participants are eligible to participate in this study if they have completed required Phase 1 study assessments for primary objectives of respective parent protocol and are having evidence of clinical benefit as defined by the parent protocol Participants will continue the most similar dose and formulation available which does not exceed the maximum tolerated dose MTD or the maximum safely administered dose for that formulation during Phase 1 and the same schedule of RO5045337 treatment that they were receiving at the time of transitioning from the parent clinical study protocol
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 |
|---|---|---|---|
| 2012-001303-20 | EUDRACT_NUMBER | None | None |