At a glance
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Bevacizumab in Patients With Metastatic Renal Cell Carcinoma or Others Advanced Solid Tumors
In Brief
A Phase 1 clinical trial evaluating Association of Bevacizumab (BVC)+ Pazopanib (PZP) for Metastatic Renal Cell Carcinoma and Advanced Refractory Solid Tumors Histologically or Cytologically Confirmed. Completed, enrolled 36 participants across 1 site.
Detailed Summary
This is an open-label, multicenter dose-escalation phase I study using a 3+3+3 design (i.e., 3 to 9 patients per dose level) in patients with mRCC or others advanced refractory solid tumors. Enrolment will be performed to include approximately ½ of patients with mRCC. The primary endpoint is the occurrence of limiting toxicities leading to definitive discontinuation of the study drugs during the first 24 weeks in absence of progression of the disease. Secondary endpoints included the occurrence of Dose Limiting Toxicities (DLTs) evaluated during the first two cycles; overall response rate, 6-months progression-free survival rate and Pharmacokinetic assessments.
Study Details
Timeline
Interventions
Treatment is administered in 28-day cycles, during which patients received BVC intravenously every 2 weeks and oral PZP once daily from days 1 to 28. For the first cycle, PZP is administered alone from days 1 to 14. The starting dose for dose escalation is BVC at 7.5 mg/kg in combination with PZP 400 mg (level 1). The therapy regimens for each dose level are respectively: BVC 7.5 mg/kg + PZP 600 mg (level 2) BVC 10 mg/kg + PZP 600 mg (level 3) BVC 10 mg/kg + PZP 800 mg (level 4). Patients who experience grades 3 to 4 adverse events have dose adjustments to one or both drugs. Dose reductions affect in priority the administration of PZP. Doses reductions to PZP are made in 200-mg decrements and to BVC to 2.5-mg/kg decrements. Patients with toxicities that warrant reductions at either PZP 400 mg or BVC 7.5 mg/kg are withdrawn from the study.