Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Voraxaze Injectable Product · 1 trial · 1 indication
absence of severe non-hematological toxicity
immediate and sustained reduction in plasma MTX concentration
| Arm | Type | Description |
|---|---|---|
| Dose escalation | EXPERIMENTAL | Patients will receive up to 6 cycles of HD-MTX Treatment Dose escalation will be performed using three dose levels of MTX: 3.0 g/m2, 3.5 g/m2, 4.0 g/m2 |
| Name | Type | Description |
|---|---|---|
| Voraxaze Injectable Product | DRUG | High-dose Methotrexat Infusion: MTX is given at a dose according to the allocated dose level cohort as a 4-hour IV infusion. HD-MTX cycles (up to 6) should be repeated every 14 days, provided that the patient has recovered (i.e., hematopoietic reconstitution) between cycles. A delay of up to 28 days between cycles is permitted in order to allow patients to recover from the preceding dose of MTX. In patients with a decline of the GFR to \<40 mL/min, or in the case of decreased GFR, the decrease is \>50% compared with the pretreatment value, treatment will be terminated. At the start of Cycle 3 the dose of MTX can be escalated to the next level if MTX has been well-tolerated according to the criteria described under dose escalation. Voraxaze: 2000 Units in patients weighing ≤100kg and at least 20 Units per kg body weight in patients weighing \>100kg is given in each HD-MTX cycle as a slow IV injection at 24 hours (+/- 2 hours) after the start of HD-MTX infusion. |
Inclusion Criteria: * Primary or secondary CNSL (PCNSL or SCNSL) confirmed by histology or cytology. * Renal insufficiency defined as a glomerular filtration rate (GFR, assessed by CKD-EPI or MDRD equation) of 40-80 mL/min or patients with a GFR \>80mL/min who have experienced renal failure, define...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Incyte Corporation | INCY | 2 | PHASE2 | Ruxolitinib, Pembrolizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | - | Undisclosed |
Voraxaze Injectable Product is an investigational small molecule being studied for use in CNS Lymphoma. It was evaluated in a Phase I/II clinical trial in Germany that enrolled 18 patients with the condition. The study has been completed, and the drug remains in clinical development.
Voraxaze Injectable Product is being developed by Pulmonx Corporation, a company traded on the stock exchange under the ticker LUNG. The company is conducting clinical research on this investigational drug for the treatment of CNS Lymphoma.
Voraxaze Injectable Product is in Phase 1 of clinical development. It has completed one Phase I/II trial for CNS Lymphoma, which enrolled 18 patients. The drug is investigational and has not been approved by regulatory authorities.
Voraxaze Injectable Product has one completed clinical trial, identified as NCT04841434. This Phase I/II study investigated the use of the drug in patients with CNS Lymphoma. The trial was conducted in Germany, enrolled 18 adults, and was not randomized or blinded.
Yes, Voraxaze Injectable Product is also known as VORAXAZE. The clinical trial NCT04841434, titled 'A Phase I/II Study to Investigate the Use of VORAXAZE™ As Intended Intervention in Patients with CNSL', used this name for the drug being studied in CNS Lymphoma.