A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. 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 Dose-escalation Study of R1507 in Patients With Advanced Solid Tumors.|
- AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Tumor response [ Time Frame: Event driven ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Study Completion Date:||April 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Administered iv, either weekly or 3 weekly, at escalating doses (with a starting dose of 1mg/kg) (7 cohorts).
|United States, Colorado|
|Aurora, Colorado, United States, 80045|
|United States, New Jersey|
|New Brunswick, New Jersey, United States, 08901|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Study Director:||Clinical Trials||Hoffmann-La Roche|