A Phase II Trial of Dovitinib in Bacillus Calmette-Guerin(BCG) Refractory Urothelial Carcinoma Patients With Tumor Fibroblast Growth Factor Receptor 3(FGFR3) Mutations or Over-expression: Hoosier Oncology Group GU12-157

Inclusion Criteria:

- Histologically confirmed early stage urothelial carcinoma of the bladder defined as
Ta, T1, or Tis stage.

- Presence of either an FGFR3 mutation or FGFR3 over-expression within bladder tumor
tissue.

- Documented BCG-refractory disease defined as failure to achieve a tumor free state
after at least 2 prior induction courses of intravesical BCG therapy.

- Medically unfit to undergo cystectomy or electively choosing to forego cystectomy

- Patients who give a written informed consent obtained according to local guidelines

Exclusion Criteria:

- Patients with muscle-invasive (i.e. T2, T3, T4), locally advanced non-resectable, or
metastatic urothelial carcinoma as assessed on baseline radiographic imaging obtained
within 28 days prior to study registration.

- Patients with concurrent upper urinary tract (i.e. ureter, renal pelvis) non-invasive
urothelial carcinoma.

- 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,
clinically localized prostate cancer, biochemically relapsed non-metastatic prostate
cancer (i.e., PSA only disease), or skin cancer (such as basal cell carcinoma,
squamous cell carcinoma, or non-melanomatous skin cancer)

- Patients who have received the last administration of an anti-cancer therapy
including chemotherapy, immunotherapy, and monoclonal antibodies ≤ 4 weeks prior to
starting study drug, or who have not recovered from the side effects of such therapy

- Patients who have received prior VEGFR-targeted or FGFR-targeted agents (i.e.,
sunitinib, pazopanib, sorafenib, bevacizumab, axitinib, etc.).

- Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or who
have not recovered from radiotherapy toxicities

- Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or
intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to
starting study drug, or patients who have had minor procedures (i.e., TURBT),
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

- Uncontrolled hypertension defined by a systolic blood pressure (SBP) ≥ 160 mm Hg
and/or d iastolic blood pressure (DBP) ≥ 100 mm Hg, with or without anti-hypertensive
medication(s)

- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of dovitinib (e.g., ulcerative diseases, uncontrolled nausea,
vomiting, diarrhea, malabsorption syndrome, or small bowel resection)

- Cirrhosis, chronic active hepatitis or chronic persistent hepatitis

- Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not
mandatory)

- Patients who are currently receiving anti-coagulation treatment with therapeutic
doses of warfarin. Full-dose anti-coagulation with low molecular weight heparin is
permitted.

- Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g.,
active or uncontrolled infection, uncontrolled diabetes) that could cause
unacceptable safety risks or compromise compliance with the protocol

- Pregnant or breast-feeding women

- Women of child-bearing potential, who are biologically able to conceive, not
employing two forms of highly effective contraception. Highly effective contraception
must be used throughout the trial and up to 8 weeks after the last dose of study drug
(e.g. male condom with spermicidal; diaphragm with spermicide; intra-uterine device).
Oral, implantable, or injectable contraceptives that may be affected by cytochrome
P450 interactions are not considered effective for this study. Women of
child-bearing potential, defined as sexually mature women who have not undergone a
hysterectomy or who have not been naturally postmenopausal for at least 12
consecutive months (i.e., who has had menses any time in the preceding 12 consecutive
months), must have a negative serum pregnancy test ≤ 14 days prior to starting study
drug.

- Fertile males not willing to use contraception, as stated above

- Patients unwilling or unable to comply with the protocol