CLINICAL TRIALS PROFILE FOR VORAXAZE

All Clinical Trials for VORAXAZE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00424645 ↗	Voraxaze for Delayed Methotrexate Clearance	Terminated	BTG International Inc.	Phase 1/Phase 2	2007-01-01	Primary Objectives: 1. To evaluate the efficacy of Glucarpidase (Voraxaze) in increasing the rate of methotrexate (MTX) clearance following high dose MTX treatment in patients with a delayed MTX clearance. 2. To evaluate the pharmacokinetics (PK) of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance. 3. To evaluate the safety profile of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance. Secondary Objectives: 1. To evaluate the effect of Glucarpidase on the incidence of neutropenic fever and use of intravenous (IV) antibiotics. 2. To evaluate the effect of Glucarpidase on the length of hospitalization. 3. To evaluate the effect of Glucarpidase on renal function. 4. To evaluate the effect of Glucarpidase on Quality of Life (QOL). 5. To evaluate the anti-glucarpidase antibody response. 6. To evaluate the efficacy of Glucarpidase following its use in repeated cycles of high dose MTX treatment.
NCT00424645 ↗	Voraxaze for Delayed Methotrexate Clearance	Terminated	M.D. Anderson Cancer Center	Phase 1/Phase 2	2007-01-01	Primary Objectives: 1. To evaluate the efficacy of Glucarpidase (Voraxaze) in increasing the rate of methotrexate (MTX) clearance following high dose MTX treatment in patients with a delayed MTX clearance. 2. To evaluate the pharmacokinetics (PK) of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance. 3. To evaluate the safety profile of Glucarpidase following high dose MTX treatment in patients with a delayed MTX clearance. Secondary Objectives: 1. To evaluate the effect of Glucarpidase on the incidence of neutropenic fever and use of intravenous (IV) antibiotics. 2. To evaluate the effect of Glucarpidase on the length of hospitalization. 3. To evaluate the effect of Glucarpidase on renal function. 4. To evaluate the effect of Glucarpidase on Quality of Life (QOL). 5. To evaluate the anti-glucarpidase antibody response. 6. To evaluate the efficacy of Glucarpidase following its use in repeated cycles of high dose MTX treatment.
NCT00481559 ↗	Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate Toxicity	Approved for marketing	CTI Clinical Trial and Consulting Services		1969-12-31	This protocol is for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function

Clinical Trial Conditions for VORAXAZE

Condition Name

Condition Name for VORAXAZE
Intervention	Trials
Osteosarcoma	3
Solid Tumor	1
Spindle Cell Sarcoma of Bone	1

Condition MeSH

Condition MeSH for VORAXAZE
Intervention	Trials
Osteosarcoma	3
Lymphoma	2
Sarcoma	1

Clinical Trial Locations for VORAXAZE

Trials by Country

Trials by Country for VORAXAZE
Location	Trials
United States	28
Germany	1
United Kingdom	1

Trials by US State

Trials by US State for VORAXAZE
Location	Trials
New York	2
New Jersey	2
Florida	2
Texas	2
Pennsylvania	2

Clinical Trial Progress for VORAXAZE

Clinical Trial Phase

Clinical Trial Phase for VORAXAZE
Clinical Trial Phase	Trials
Phase 2	1
Phase 1/Phase 2	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for VORAXAZE
Clinical Trial Phase	Trials
Recruiting	3
Terminated	2
Approved for marketing	1

Clinical Trial Sponsors for VORAXAZE

Sponsor Name

Sponsor Name for VORAXAZE
Sponsor	Trials
BTG International Inc.	4
M.D. Anderson Cancer Center	1
CTI Clinical Trial and Consulting Services	1

Sponsor Type

Sponsor Type for VORAXAZE
Sponsor	Trials
Other	13
NIH	1