Rasburicase (Fasturtec) Registration Trial

Official Title: “A Randomized, Multicenter, Open-label, Comparison of Rasburicase (Fasturtec) Versus Allopurinol for the Prophylaxis and Treatment of Hyperuricemia in Chinese Patients With Leukaemia or Lymphoma”

Primary:

To compare the efficacy of Rasburicase versus allopurinol in controlling tumor lysis-related hyperuricemia in Chinese patients with leukemia or lymphoma.

Secondary:

To compare the efficacy and safety of Rasburicase versus allopurinol in Chinese patients stratified according to disease (leukemia or lymphoma ).

Intervention(s) in this Clinical Trial

• Drug: Rasburicase
  • 0.20mg/kg per day IV
• Drug: Allopurinol
  • 100mg tablets

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • IV infusion at a dose level of 0.20mg/kg per day
• Active Comparator: 2
  • 100mg tablets, administered orally, according to standard medical practice

Primary Measures

• Mean plasma uric acid AUC0-96
  • Time Frame: 0hour, 4hour, 12 hour and q12h thereafter
    Safety Issue?: No
• Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL (only in patients hyperuricemic immediately prior to dosing)
  • Time Frame: From administration of drug up to end of study
    Safety Issue?: No
• Biochemistry, hematology, vital signs, physical examination, and adverse events
  • Time Frame: From administration of drug up to end of study
    Safety Issue?: No
• Proportion of patients developing hypertension requiring therapy
  • Time Frame: From administration of drug up to end of study
    Safety Issue?: No
• Assays for circulating antibodies
  • Time Frame: From administration of drug up to end of study
    Safety Issue?: No

Secondary Measures

• Percentage reduction of plasma uric acid concentrations at T4h
  • Time Frame: From administration of drug up to end of study
    Safety Issue?: No
• Mean plasma uric acid concentrations
  • Time Frame: At various timepoints
    Safety Issue?: No
• Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL
  • Time Frame: From administration of drug up to end of study
    Safety Issue?: No

Inclusion Criteria:

• At high risk of malignancy and/or chemotherapy-induced hyperuricemia
• Performance status less than 3 on ECOG scale or more than 30% KPS scale
• Uric acid concentrations ≥ 8.0mg/dL
• Suffering from non-Hodgkin's lymphoma Stage more than III, or acute lymphoblastic leukemia with peripheral with blood cell count more than 25,000/mm3, or any lymphoma or leukemia

Exclusion Criteria:

• Treatment with an investigational drug at any time during the 14-day study period (except for agents that are permitted by the Sponsor)
• Pregnancy or lactation
• Prior treatment with Uricozyme or Rasburicase
• Scheduled to receive asparaginase either 24 hours after the first dose of rasburicase
• Treatment with Allopurinol within the seven days preceding study Day 1
• History of significant atopic allergy problems or documented history of asthma
• History of severe reaction to allopurinol
• Known history of glucose-6-phosphate dehydrogenase deficiency.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

Jing Fu Study Director Sanofi-Aventis  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00607152

Study ID Number: RASBU_L_00351

ClinicalTrials.gov Identifier: NCT00607152

Health Authority: China: State Food and Drug Administration