CLINICAL TRIALS PROFILE FOR GLUCARPIDASE
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All Clinical Trials for glucarpidase
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00018967 ↗ | Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate | Completed | Children's Oncology Group | N/A | 1993-11-01 | RATIONALE: Chemoprotective drugs such as carboxypeptidase-G2 may protect normal cells from the toxic effects of chemotherapy. PURPOSE: Clinical trial to study the effectiveness of carboxypeptidase-G2 in treating nervous system toxic effects in patients given an accidental overdose of intrathecal methotrexate. |
| NCT00018967 ↗ | Carboxypeptidase-G2 in Treating Nervous System Toxic Effects in Patients Given an Overdose of Intrathecal Methotrexate | Completed | National Cancer Institute (NCI) | N/A | 1993-11-01 | RATIONALE: Chemoprotective drugs such as carboxypeptidase-G2 may protect normal cells from the toxic effects of chemotherapy. PURPOSE: Clinical trial to study the effectiveness of carboxypeptidase-G2 in treating nervous system toxic effects in patients given an accidental overdose of intrathecal methotrexate. |
| NCT00219791 ↗ | Study of Glucarpidase (CPG2) for the Management of Patients With Delayed Methotrexate Clearance | Completed | BTG International Inc. | Phase 2 | 2000-01-01 | To evaluate the safety and efficacy of glucarpidase in patients with impaired methotrexate (MTX) clearance owing to MTX-induced renal failure following high-dose MTX therapy, or with intrathecal MTX overdose. |
| 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. |
| NCT00634322 ↗ | High Dose Methotrexate With Leucovorin Rescue With or Without Glucarpidase in Osteosarcoma | Terminated | M.D. Anderson Cancer Center | Phase 2 | 2008-10-01 | The purpose of this study is to demonstrate whether use of glucarpidase facilitates administration of the next cycle of chemotherapy as scheduled and improves safety and tolerability of HDMTX given with LV |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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