A Phase 1 interventional study of glucarpidase, high-dose methotrexate, leucovorin and high-dose methotrexate, leucovorin in Osteosarcoma, Leukemia and Lymphoma, sponsored by BTG International Inc.. Completed at 25 sites in United States. Per ClinicalTrials.gov, last updated 2022-06-06.
Sponsored by BTG International Inc. · Phase 1, Interventional, and Treatment
The purpose of this study is to investigate whether the administration of Voraxaze reduces exposure to leucovorin and its active metabolite to below the level achieved in patients who have not received Voraxaze.
488 studies on the registry are indexed under Osteosarcoma; 124 are open to participants now.
This study's enrollment of 20 is below the median of 40 across 354 interventional studies indexed under Osteosarcoma.
Browse Osteosarcoma studies →BTG International Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.
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High-dose methotrexate, leucovorin, and Voraxaze
Drug: glucarpidase, high-dose methotrexate, leucovorin
High-dose methotrexate and leucovorin without Voraxaze (glucarpidase)
Drug: high-dose methotrexate, leucovorin
Drug pages: Glucarpidase · Methotrexate · Leucovorin
single intravenous dose
Also known as: Voraxaze, carboxypeptidase G2, high dose methotrexate, leucovorin
Drug pages: Methotrexate · Leucovorin
standard of care, leucovorin every 6 hours
Also known as: HDMTX, LV
Pharmacokinetics (PK) of Leucovorin
Geometric mean (6S)-leucovorin area under the plasma concentration vs. time curve from time 0 to the 3-hour time point.
Time frame: 5 minutes, 30 minutes, 1 hour, 2 hours and 3 hours post-LV administration
| Milestone | A (High-dose Methotrexate, Leucovorin, and Glucarpidase) | B (High-dose Methotrexate and Leucovorin Without Glucarpidase) |
|---|---|---|
| Started | 11 | 9 |
| Completed | 10 | 9 |
| Not completed | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 |
Geometric mean (6S)-leucovorin area under the plasma concentration vs. time curve from time 0 to the 3-hour time point.
| micromol x hour/L | A (High-dose Methotrexate, Leucovorin, and Glucarpidase) | B (High-dose Methotrexate and Leucovorin Without Glucarpidase) |
|---|---|---|
| Pharmacokinetics (PK) of Leucovorin | 6.43 (2.89 to 14.32) | 1.13 (0.72 to 1.75) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| A (High-dose Methotrexate, Leucovorin, and Glucarpidase) | — | 3/11 (27.3%) | 7/11 (63.6%) |
| B (High-dose Methotrexate and Leucovorin Without Glucarpidase) | — | 0/9 (0%) | 0/9 (0%) |
| Event | A (High-dose Methotrexate, Leucovorin, and Glucarpidase) | B (High-dose Methotrexate and Leucovorin Without Glucarpidase) |
|---|---|---|
| renal failureRenal and urinary disorders | 1/11 | 0/9 |
| febrile neutropeniaBlood and lymphatic system disorders | 1/11 | 0/9 |
| hepatic failureHepatobiliary disorders | 1/11 | 0/9 |
| Event | A (High-dose Methotrexate, Leucovorin, and Glucarpidase) | B (High-dose Methotrexate and Leucovorin Without Glucarpidase) |
|---|---|---|
| neutropeniaBlood and lymphatic system disorders | 4/11 | 0/9 |
| leukopeniaBlood and lymphatic system disorders | 3/11 | 0/9 |
| hypertensionVascular disorders | 3/11 | 0/9 |
| febrile neutropeniaBlood and lymphatic system disorders | 2/11 | 0/9 |
| thrombocytopeniaBlood and lymphatic system disorders | 2/11 | 0/9 |
| hemoglobin decreasedInvestigations | 2/11 | 0/9 |
| hypocalcemiaMetabolism and nutrition disorders | 2/11 | 0/9 |
| hypokalemiaMetabolism and nutrition disorders | 2/11 | 0/9 |
| mucosal inflammationGeneral disorders | 2/11 | 0/9 |
| lymphopeniaBlood and lymphatic system disorders | 1/11 | 0/9 |
Safety population
| Age, Continuous(years) | A (High-dose Methotrexate, Leucovorin, and Glucarpidase) | B (High-dose Methotrexate and Leucovorin Without Glucarpidase) | Total |
|---|---|---|---|
| Mean | 26.4 ± 22.07 | 12.6 ± 7.84 | 20.2 ± 18.22 |
| Sex: Female, Male(Participants) | A (High-dose Methotrexate, Leucovorin, and Glucarpidase) | B (High-dose Methotrexate and Leucovorin Without Glucarpidase) | Total |
|---|---|---|---|
| Female | 5 | 2 | 7 |
| Male | 6 | 7 | 13 |
| Race (NIH/OMB)(Participants) | A (High-dose Methotrexate, Leucovorin, and Glucarpidase) | B (High-dose Methotrexate and Leucovorin Without Glucarpidase) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 6 | 7 | 13 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Pre-glucarpidase (Arm A) or Pre-LV (Arm B) methotrexate plasma conc (umol/L)(micromol/L) | A (High-dose Methotrexate, Leucovorin, and Glucarpidase) | B (High-dose Methotrexate and Leucovorin Without Glucarpidase) | Total |
|---|---|---|---|
| Mean | 34.58 ± 48.59 | 6.49 ± 11.00 | 21.94 ± 21.94 |
The record gives a start of May 2008, a primary completion of Aug 2009 and a completion of Aug 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2014, 4 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Glucarpidase · Methotrexate · Leucovorin
BTG International Inc.