Phase II Study of Dovitinib and Pilot Study of Fibroblast Growth Factor Receptor Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer Previously Treated With Anti-Vascular Endothelial Growth Factor Therapy

Date de début de l'étude : 1 février 2013

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