A Study of R547 in Patients With Advanced Solid Tumors.
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Pharmacokinetic and pharmacodynamic profiles of R547 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Administered iv on days 1 and 8 of a 3 week cycle at escalating doses to successive groups of patients until MTD is reached.
|United States, Colorado|
|Aurora, Colorado, United States, 80045|
|United States, New Jersey|
|New Brunswick, New Jersey, United States, 08901|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28203|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Study Director:||Clinical Trials||Hoffmann-La Roche|