A Phase 1b Study Of Axitinib In Combination With Crizotinib In Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

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. It is proposed that mesenchymal-epithelial transition factor (c-MET) and its ligand hepatocyte growth factor (HGF or scatter factor) contribute 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 the VEGF inhibitor, axitinib.Since this will be the first study of axitinib given in combination with crizotinib, the study will primarily assess the safety and tolerability of the combination regimen.

Key facts

Study ID

NCT01999972

Run by

Pfizer

People needed

50

Starts

2014-02-26

Expected to finish

2019-09-05

Last updated by the study team

2020-09-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis - Dose Escalation Phase: Histologically or cytologically confirmed diagnosis of advanced solid tumor that is resistant to standard therapy or for which no standard therapy is available.
• Diagnosis - Dose Expansion Phase: Histologically or cytologically confirmed advanced RCC with a component of clear cell subtype
• Dose Expansion Phase: at least one measureable lesion as defined by RECIST [Response Evaluation Criterion in Solid Tumors] version 1.1.
• ECOG [Eastern Cooperative Oncology Group] Performance Status 0 or 1.

You may not qualify if…

• Major surgery <4 weeks or radiation therapy <2 weeks of patient registration.
• History of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
• Dose Expansion Phase only: diagnosis of any other malignancy within 2 years prior to registration.

Where it is running

• University of Chicago Medical Center — Chicago, Illinois, United States
• Investigational Drug Services IUHSCC — Indianapolis, Indiana, United States
• IU Health University Hospital — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Wayne State University, Dept. of Oncology — Detroit, Michigan, United States
• University of Minnesota Health Clinics and Surgery Center — Minneapolis, Minnesota, United States
• University of Minnesota Medical Center, Fairview IDS Pharmacy — Minneapolis, Minnesota, United States
• University of Minnesota Medical Center, Fairview — Minneapolis, Minnesota, United States
• University of Minnesota Physicians Masonic Cancer Center — Minneapolis, Minnesota, United States
• Cleveland Clinic Taussig Cancer Center Investigational Pharmacy — Cleveland, Ohio, United States
• Huntsman Cancer Hospital — Salt Lake City, Utah, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• John A Moran Eye Center — Salt Lake City, Utah, United States
• University Station Ophthalmology Clinic — Madison, Wisconsin, United States
• University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• St Bartholomew's Hospital - Barts Health NHS Trust — London, United Kingdom
• The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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