Spots Global Cancer Trial Database for A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
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Trial Identification
Brief Title: A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
Official Title: A Dose-escalation Study of R1507 in Patients With Advanced Solid Tumors.
Study ID: NCT00400361
Conditions
Interventions
Study Description
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Aurora, Colorado, United States
, New Brunswick, New Jersey, United States
, Houston, Texas, United States
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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