NCT01441388

A Study Of Crizotinib Plus VEGF Inhibitor Combinations In Patients With Advanced Solid Tumors.

A Phase 1B, Open-Label, Dose Escalation Study To Evaluate Safety, Pharmacokinetics And Pharmacodynamics Of Crizotinib (PF-02341066) Plus VEGF Inhibitor Combinations In Patients With Advanced Solid Tumors.

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Despite the success of anti-angiogenic therapy in multiple treatment settings, a fraction of patients are refractory to vascular endothelial growth factor (VEGF) inhibitor treatment while the majority of patients will eventually develop evasive resistance and exhibit disease progression while on therapy. It is proposed that mesenchymal-epithelial transition factor (c-MET) and its ligand hepatocyte growth factor (HGF or scatter factor) contribute significantly to VEGF inhibitor resistance such that combining a c-MET inhibitor with a VEGF inhibitor will provide additional clinical activity compared to VEGF inhibitor alone. This hypothesis will be tested using the cMET/ALK inhibitor, crizotinib, in combination with individual VEGF inhibitors. Three combinations will be prioritized, namely crizotinib plus axitinib, crizotinib plus sunitinib and crizotinib plus bevacizumab, with a fourth combination, crizotinib plus sorafenib to be tested only if crizotinib does not combine with either axitinib and/or sunitinib.

Conditions

• Carcinoma, Renal Cell
• Glioblastoma
• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
DRUG	Crizotinib plus VEGF inhibitor combinations	Three combinations will be prioritized, namely crizotinib plus axitinib, crizotinib plus sunitinib and crizotinib plus bevacizumab, with a fourth combination, crizotinib plus sorafenib to be tested only if crizotinib does not combine with either axitinib and/or sunitinib. All study drugs are tablets or capsules except for bevacizumab which is parenteral (intravenous). Dosage, frequency and duration to be determined.
DRUG	Crizotinib plus axitinib	Study drugs are tablets or capsules; dosage, frequency and duration to be determined.
DRUG	Crizotinib plus sunitinib	Study drugs are tablets or capsules; dosage, frequency and duration to be determined.
DRUG	Crizotinib plus axitinib	Study drugs are tablets or capsules; dosage, frequency and duration to be determined.
DRUG	Crizotinib plus sunitinib	Study drugs are tablets or capsules; dosage, frequency and duration to be determined.
DRUG	Crizotinib plus bevacizumab	Study drugs are tablets or capsules except for bevacizumab which is parenteral (intravenous). Dosage, frequency and duration to be determined.
DRUG	Crizotinib plus sorafenib	Study drugs are tablets or capsules; dosage, frequency and duration to be determined.

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2011-09-27
• Last updated: 2011-12-20