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

The purposes of this study are 1) to evaluate the clinical efficacy of dovitinib and 2) to
prospectively estimate the prevalence of fibroblast growth factor (FGF) signaling alterations
in patients with advanced non-squamous non small cell lung cancer (NSCLC) or advanced CRC who
have progressed on anti-VEGF treatment. Additionally, the investigators will make exploratory
initial observations of the relationship between FGF signaling alterations and the clinical
activity of dovitinib. This trial is expected to provide key biologic information that will
inform the clinical development of dovitinib and provide initial evaluation of the analytic
characteristics of these potential predictive biomarkers of its efficacy.

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