Kidney Cancer Clinical Trial

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

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. 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT01999972

Recruitment Status:

Completed

Sponsor:

Pfizer

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There are 12 Locations for this study

See Locations Near You

University of Chicago Medical Center
Chicago Illinois, 60637, United States
Investigational Drug Services IUHSCC
Indianapolis Indiana, 46202, United States
IU Health University Hospital
Indianapolis Indiana, 46202, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Wayne State University, Dept. of Oncology
Detroit Michigan, 48201, United States
University of Minnesota Health Clinics and Surgery Center
Minneapolis Minnesota, 55455, United States
University of Minnesota Medical Center, Fairview IDS Pharmacy
Minneapolis Minnesota, 55455, United States
University of Minnesota Medical Center, Fairview
Minneapolis Minnesota, 55455, United States
University of Minnesota Physicians Masonic Cancer Center
Minneapolis Minnesota, 55455, United States
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland Ohio, 44106, United States
Huntsman Cancer Hospital
Salt Lake City Utah, 84112, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
John A Moran Eye Center
Salt Lake City Utah, 84132, United States
University Station Ophthalmology Clinic
Madison Wisconsin, 53705, United States
University of Wisconsin Hospital and Clinics
Madison Wisconsin, 53792, United States
St Bartholomew's Hospital - Barts Health NHS Trust
London , EC1A , United Kingdom
The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital
London , SW3 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

50

Study ID:

NCT01999972

Recruitment Status:

Completed

Sponsor:


Pfizer

How clear is this clinincal trial information?

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