Trial information
A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
Status: Recruiting
Protocol number: BO19373
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A dose-escalation study of R1507 in patients with advanced solid tumors.
Brief summary: 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. Target sample size is 93.
Study phase: I
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: Neoplasms
Intervention type: Drug
Intervention name: R1507
Primary outcome: 1. AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life Time frame: Throughout study
Key secondary outcomes: 1. Tumor response Time frame: Event driven
Inclusion criteria:
- adult patients, >=18 years of age;
- solid neoplasm, non-Hodgkin's lymphoma or Hodgkin's lymphoma;
- metastatic or locally advanced disease, not curable by any currently available treatment.
Exclusion criteria:
- severe, uncontrolled systemic disease;
- patients who require treatment with glucocorticoids or immunosuppressive treatment within last 6 months;
- patients with diabetes mellitus.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: April, 2006
Trial registration date: 11/16/2006
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:
United States
- Aurora, CO
- New Brunswick, NJ
- Houston, TX
- San Antonio, TX
