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

• Drug: axitinib
  
  Axitinib: tablets, dosage range 2 - 5 mg, given orally twice daily on a continuous dosing schedule in 28 days cycles.
• Drug: crizotinib
  
  Crizotinib: capsules, dosage range 200-250 mg, given orally twice daily or every day on a continuous dosing schedule in 28 days cycle.
• Drug: axitinib
  
  Axitinib: tablets, dosage be defined based on Arm 1 results, given orally twice daily on a continuous dosing schedule in 28 days cycles.
• Drug: crizotinib
  
  Crizotinib: capsules, dosage be defined based on Arm 1 results, given orally twice daily or every day on a continuous dosing schedule in 28 days cycle.

• Experimental: Axitinib in combination with crizotinib, escalation phase
  
  Dose Escalation Advanced solid tumor that is resistant to standard therapy or for which no standard therapy is available
  Interventions:
  

  • Drug: axitinib
  • Drug: crizotinib
• Experimental: Expansion Phase Cohort 1
  
  Dose Expansion, Cohort 1: axitinib in combination with crizotinib Advanced renal cell cancer [RCC] with no prior systemic therapy
  Interventions:
  

  • Drug: axitinib
  • Drug: crizotinib
• Experimental: Expansion Phase Cohort 2
  
  Dose Expansion, Cohort 2: axitinib in combination with crizotinib Advanced renal cell cancer with at least one but no more than two prior systemic treatment regimens directed at advanced RCC
  Interventions:
  

  • Drug: axitinib
  • Drug: crizotinib

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.