Maintenance Dovitinib for Colorectal and Pancreas Cancer

This is a single institution, nonrandomized, open-label pilot study of dovitinib as
maintenance and adjuvant therapy in patients with colorectal and pancreas cancers.

Patient Populations:

Cohort 1: Stage 4 Colon Cancer s/p metastasectomy (Adjuvant cohort)

Cohort 2: Stage 4 Colon Cancer after initial chemotherapy (Maintenance cohort)

Cohort 3: Pancreas Cancer s/p resection and adjuvant chemo (Adjuvant cohort)

Cohort 4: Locally advanced pancreas cancer s/p chemo and radiation (Maintenance cohort)

Each of the 4 cohorts will be accrued independently. 15 patients will be accrued to each
cohort. Treatment will begin following the completion of the standard adjuvant or induction
therapy. Patients will continue to take dovitinib until they demonstrate progression of
disease using standard RECIST criteria, withdraw consent, or experience unacceptable
toxicity.

Blood and urine Biomarker studies will be performed on all patients in all cohorts. Samples
will be collected at baseline and every 8 weeks for the first 6 months and then every 3
months thereafter, while patients are on study. Blood and urine will be collected and banked
for protein, miRNA and metabolomic analysis. Tumor specimens will be taken from patients in
maintenance cohorts before and 2 weeks after initiation of dovitinib. All of these samples
will be analyzed to determine if biomarkers of benefit and progression can be determined.

Inclusion Criteria:

- Patients with a confirmed diagnosis of:

1. Stage 4 colon cancer either s/p metastasectomy or post-initial chemotherapy or
maintenance "standard of care", either involving 5-FU/LV alone or continual
bevacizumab alone. Patients in maintenance cohort must have had 2 consecutive CT
scans showing stable disease and not be experiencing significant prior
treatment-related toxicity above Grade 1.

2. Pancreas cancer, either s/p resection and adjuvant chemotherapy or locally
advanced pancreas cancer s/p chemotherapy and radiation. Initial chemotherapy or
radiation therapy may have been stopped between 2 weeks and 2 months prior to
study start, and patients must have recovered from prior treatment related
toxicity to grade 1 or less.

- Prior surgery, including tumor resection or metastasectomy must have been performed
at least 4 weeks prior to study enrollment.

- No concomitant anti-cancer treatment is allowed

- Age >/= 18 years

- Performance status of 0-1

- Adequate hepatic, bone marrow, and renal function

- Partial thromboplastin time (PTT) must be institution's normal range and INR (International Normalized Ratio) < 1.5.

- Life expectancy >/= 4 months for maintenance cohorts and >/= 6 months for adjuvant
cohorts

- Women of childbearing potential must have a negative serum pregnancy test within 14
days prior to initiation of treatment and must not be lactating.

- Subject is capable of understanding and complying with protocol demands and able to
sign and date the informed consent

Exclusion Criteria:

- Women of child-bearing potential, who are biologically able to conceive, not
employing two forms of highly effective contraception or who are pregnant.

- Women who are breast-feeding

- Fertile males unwilling to use contraception

- Patients with brain metastases or any history of brain metastases

- Patients who have undergone major surgery (e.g., intra-thoracic, -abdominal, or
-pelvic) such therapy

- Patients with a history of pulmonary embolism, or untreated deep vein thrombosis
within the past 6 months

- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of dovitinib

- The subject has had another active malignancy within the past 5 years except for
cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma
of the skin.

- Patients who have received the last administration of an anticancer therapy including
chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies prior to starting the study drug, or who have not recovered from the side effects of
such therapy

- Cirrhosis, chronic active hepatitis or chronic persistent hepatitis

- Patients who are currently receiving prasugrel

- No concurrent use of isoniazid, labetolol, trovafloxacin, tolcapone, and felbamate

- No concurrent use of other investigational drugs or antineoplastic therapies.

- Patients with impaired cardiac function or clinically significant cardiac diseases.