Study of Dovitinib and Biomarkers in Advanced Non-Small Cell Lung Cancer or Advanced Colorectal Cancer
Condition: Non-Small Cell Lung Cancer; Colorectal Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms
Intervention: Dovitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dovitinib; Fibroblast Growth Factor Receptor Biomarkers; Anti-Vascular Endothelial Growth Factor Therapy

Summary:

      The purpose of this study is to find out if dovitinib is an effective treatment for patients
      with advanced lung cancer or advanced colorectal cancer (CRC) who have progressed on
      anti-vascular endothelial growth factor (VEGF) treatment.
    

Eligibility criteria:

        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