A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy
Completed
Jazz Pharmaceuticals
Phase 2
2012-11-01
This study will utilize Erwinaze via intravenous administration in patients between the ages
of 1 and 30 who have experienced an allergy to their frontline therapy. The study will
determine the proportion of patients with 2 day nadir serum asparaginase activity levels that
are >0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.
An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)
Withdrawn
Jazz Pharmaceuticals
Phase 2
2014-05-01
The purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18
to <40 years with ALL or LBL who have developed a hypersensitivity to native E. coli
asparaginase or pegaspargase.
1336GCC: Study of Erwinaze for Treatment of Acute Myeloid Leukemia (AML)
Completed
Ashkan Emadi
Phase 1
2014-04-01
Erwinaze will be administered intravenously at a dose of 25,000 IU/m2 (dose cohort 0) for 6
doses MWF over a period of 2 weeks to 9 patients (as described below and in the following
schema). Blood counts, chemistries including bilirubin, amylase and lipase, and coagulation
studies including fibrinogen will be measured and reviewed before each asparaginase dose.
Fibrinogen (<100 mg/dL) can be replaced with cryoprecipitate before each dose at the
discretion of treating physician. Treatment will be stopped for elevation of amylase, lipase
or direct bilirubin above normal range.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.