Rasburicase (Fasturtec) Registration Trial

A Multi-center, Randomized, Open-label, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Rasburicase (Fasturtec®) in the Prevention and Treatment of Hyperuricemia in Patients With Hematological Malignancies

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 ).

Study Overview

• Status: Terminated
• Conditions: Hyperuricemia
• Intervention / Treatment: Drug: Rasburicase; Drug: Allopurinol

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; IV infusion at a dose level of 0.20mg/kg per day	Drug: Rasburicase; 0.20mg/kg per day IV
Active Comparator: 2; 100mg tablets, administered orally, according to standard medical practice	Drug: Allopurinol; 100mg tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean plasma uric acid AUC0-96	0hour, 4hour, 12 hour and q12h thereafter
Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL (only in patients hyperuricemic immediately prior to dosing)	From administration of drug up to end of study
Biochemistry, hematology, vital signs, physical examination, and adverse events	From administration of drug up to end of study
Proportion of patients developing hypertension requiring therapy	From administration of drug up to end of study
Assays for circulating antibodies	From administration of drug up to end of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage reduction of plasma uric acid concentrations at T4h	From administration of drug up to end of study
Mean plasma uric acid concentrations	At various timepoints
Median duration of therapy until control of plasma uric acid values to <8.0 mg/dL	From administration of drug up to end of study

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Jing Fu, Sanofi

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: January 22, 2008
• First Submitted That Met QC Criteria: January 22, 2008
• First Posted (Estimate): February 5, 2008

Study Record Updates

• Last Update Posted (Estimate): May 8, 2014
• Last Update Submitted That Met QC Criteria: May 7, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Protective Agents; Antioxidants; Free Radical Scavengers; Gout Suppressants; Rasburicase; Allopurinol
• Other Study ID Numbers: RASBU_L_00351