Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00400296
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2006-11-15
Brief Title:
A Study of R547 in Patients With Advanced Solid Tumors
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Multiple Ascending Dose MAD Study of R547 Administered as an Intravenous Infusion on a Weekly Schedule in Patients With Advanced Solid Tumors
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 single arm study will determine the maximum tolerated dose and recommended dose for further development of R547 in patients with advanced solid tumors Groups of patients will receive ascending doses of R547 as weekly intravenous infusions administered over a 90 minutes and b 180 minutes on days 1 and 8 of a 21 day cycle In the absence of dose-limiting toxicity following the starting dose incremental dose-escalations will be allowed in subsequent cohorts of patients until the maximum tolerated dose is reached The anticipated time on study treatment is until disease progression or dose-limiting toxicity and the target sample size is 100 individuals
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