Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-01-08 @ 4:40 PM
Study NCT ID:
NCT00559533
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2007-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of RO5045337 [RG7112] in Patients With Advanced Solid Tumors
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
A Multi-center, Open-label, Phase I Study of Single Agent R7112 Administered Orally in Patients With Advanced Malignancies, Except All Forms of Leukaemia
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 study will determine the maximum tolerated dose and the optimal associated 4 weekly dosing schedule of RO5045337, administered as monotherapy in patients with advanced solid tumors. A first cohort of patients will receive the starting dose of 20mg/m2/day, once daily for 10 days in each 28 day cycle. Subsequent cohorts of patients will receive dose escalations, and possible changes in dosing schedule, based on tolerability and pharmacokinetic knowledge gained from prior treatment cohorts. The anticipated time on study treatment is until disease progression or intolerable toxicity.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: