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Also known as Sunitinib Malate Continuous Daily Dosing
Sunitinib Continuous Daily Dosing · 1 trial · 1 indication
MSKCC Prognostic Factor Model assessed as low(0),intermediate(1-2) or high(=\>3) based on number of criteria present such as Karnofsky performance status \< 80 %, Lactate dehydrogenase \> 1.5 \* Upper limit of Normal,Hemoglobin \< lower limit of normal, serum calcium \> 10 mg/dL;Time from first diagnosis of renal cell carcinoma to start of systemic therapy of \< 1 year.TTP was time from start of study treatment to first documentation of objective tumor progression or death due to cancer.TTP was calculated as (first event date minus date of first dose of study medication plus 1) divided by 30.44.
| Arm | Type | Description |
|---|---|---|
| C | EXPERIMENTAL | - |
| A | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Sunitinib Malate Continuous Daily Dosing | DRUG | Sunitinib malate starting dose 37.5 mg daily continuous daily regimen. |
| Sunitinib Malate Schedule 4/2 | DRUG | Sunitinib malate starting dose 50 mg per day for four weeks, followed by a two week off-drug period. This six week cycle is repeated. |
Inclusion Criteria: * Advanced renal cell carcinoma of clear cell origin or a component of clear cell histology. * Measurable disease Exclusion Criteria: * Prior systemic therapy of any kind for advanced renal cell cancer * History of brain metastases * Uncontrolled hypertension
Sunitinib Continuous Daily Dosing is an investigational dosing schedule of sunitinib malate, a small molecule kinase inhibitor developed by Pfizer, Inc. (PFE). It is being studied in renal cell carcinoma, where the drug is given on a continuous daily basis rather than the intermittent 4/2 schedule. It remains in Phase 2 clinical development.
Sunitinib Continuous Daily Dosing is being evaluated as first-line therapy for metastatic renal cell carcinoma, a type of kidney cancer. The Phase 2 trial NCT00267748 compared this continuous schedule against the standard 4/2 intermittent schedule in adults with the condition. It is not yet approved for this use.
Sunitinib Continuous Daily Dosing targets multiple receptor tyrosine kinases, including CSF1R, KIT, FLT1, KDR, FLT4, and PDGFRA. As an inhibitor, it blocks signaling through these targets, which are involved in tumor angiogenesis and growth. This multi-target profile underlies its study in renal cell carcinoma.
Sunitinib Continuous Daily Dosing is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor of the clinical program evaluating this dosing schedule in renal cell carcinoma.
Sunitinib Continuous Daily Dosing is in Phase 2 clinical development. The only listed trial, NCT00267748, is a completed Phase 2 study. The drug is investigational and has not been approved for any indication in this continuous dosing form.
Sunitinib Continuous Daily Dosing has been studied in one completed Phase 2 trial, NCT00267748, titled Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer. The trial enrolled 317 adults in the United States and was randomized and controlled.
Yes, Sunitinib Continuous Daily Dosing is also known as Sunitinib Malate Continuous Daily Dosing. Both names refer to the same investigational dosing schedule of sunitinib malate developed by Pfizer, Inc. for renal cell carcinoma.