Study of Dovitinib and Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer

Inclusion Criteria:

• Histologically confirmed non-small cell lung cancer or colorectal cancer for which no potentially curative treatment options are available
• Any number of prior treatment regimens are allowed
• Immediate prior treatment regimen must have included an anti-VEGF agent. Acceptable anti-VEGF therapy includes bevacizumab, sunitinib, or sorafenib. For other anti-VEGF therapies, contact the principal investigator.
• Last dose administered of bevacizumab must be at least 21-days but not more than 56-days from enrollment.
• Last dose of anti-VEGF tyrosine kinase inhibitor must be at least 7-days but not more than 56-days from enrollment.
• Willingness to consent to research biopsy
• Measurable disease by RECIST 1.1 criteria
• Available tumor site amenable to core needle biopsy as determined by the treating investigator. Any questions regarding suitability of site for biopsy will be adjudicated by the principal investigator.
• Zubrod (ECOG) performance status 0 or 1
• Age ≥ 18 years old
• Patients who give a written informed consent

• Patients must have the following laboratory values:

  • Platelets ≥ 100 x 109/L
  • Absolute neutrophil count ≥ 1.5 x 109/L Hemoglobin > 9 g/dL
  • Serum total bilirubin: ≤ 1.5 x upper limit of normal ULN
  • ALT and AST ≤ 3.0 x ULN ( with or without liver metastases)
  • Serum creatinine ≤ 1.5 x ULN or serum creatinine >1.5 - 3 x ULN

Exclusion Criteria:

• Patients with known brain metastases
• Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer
• Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies that have not resolved to NCI CTCAE grade 1 or less.
• Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6 weeks prior to starting study drug, or who have side effects that have not resolved to NCI CTCAE grade 1 or less.
• Patients who have received targeted therapy ≤ 1 week prior to starting study drug, or who have not recovered from the side effects of such therapy
• Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or ≤ 2 weeks prior to starting study drug in the case of localized radiotherapy or who have not recovered from radiotherapy toxicities
• Patients who have undergone major surgery, open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury

• Patients with any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:

  • Impaired cardiac function or clinically significant cardiac diseases
  • Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib
  • Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
  • Known diagnosis of human immunodeficiency virus infection
  • Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin
  • Other concurrent severe and/or uncontrolled concomitant medical conditions
• Pregnant or breast-feeding women
• Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception.
• Fertile males not willing to use contraception, as stated above
• Patients unwilling or unable to comply with the protocol