FASN Inhibitor TVB-2640 in Treating Patients with Colon or Other Cancers That Can Be Removed by Surgery

Inclusion Criteria

• Patients with histologically or cytologically confirmed colon or other cancers, who are candidates for surgical resection of the tumor and will not be receiving chemotherapy and/or radiation therapy prior to resection
• Be willing and able to provide written informed consent prior to initiation of any study procedures
• Be male or female who is >= 18 years of age on day of signing informed consent. Because no dosing or adverse event data are currently available on the use of TVB-2640 in patients < 18 years of age, children are excluded from this study
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 (fully active, able to carry out all pre-disease activities without restriction) or 1 (unable to perform physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature)
• Hemoglobin >= 9 g/dL
• Absolute neutrophil count (ANC) count >= 1.5 X 10^9/L
• Platelets >= 100 X 10^9/L
• Bilirubin < 2 x upper limit of normal (ULN) and
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 X ULN
• Creatinine =< 2 x normal institutional limits OR creatinine clearance >= 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal as defined by the Cockcroft-Gault equation
• Patient has no significant ischemic heart disease or myocardial infarction (MI) within 6 months before the first dose of TVB 2640 and currently has adequate cardiac function, as evidenced by a left ventricular ejection fraction (LVEF) of >= 50% as assessed by multi-gated acquisition (MUGA) or ultrasound/echocardiography (ECHO); and corrected QT interval (QTc) < 470 msec on screening electrocardiogram (EKG)
• Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
• Female patients of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 90 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
• Male patients should agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy, or documented to be surgically sterile
• Be willing to participate in the study and comply with all study requirements

Exclusion Criteria

• Patient is unable to swallow oral medications or has impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption (including, but not limited to active inflammatory bowel disease, malabsorption syndrome); concomitant therapy with antacids and anti-emetics is permissible
• History of risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome); concomitant use of medications with a low risk of QT/QTc prolongation (including, but not limited to diphenhydramine, famotidine, ondansetron) is permissible
• Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
• Having received cancer-directed therapy (chemotherapy, radiotherapy, hormonal therapy, biologic or immunotherapy, etc) or an investigational drug within 4 weeks (6 weeks for mitomycin C and nitrosoureas) or 5 half-lives of that agent (whichever is shorter) before the first dose of study drug
• Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 90 days after the last dose of trial treatment; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TVB-2640, breastfeeding should be discontinued if the mother is treated with TVB-2640
• Inoperable on the basis of co-existent medical problems
• Patient has history of clinically significant dry eye (xerophthalmia) or other corneal abnormality or, if a contact lens wearer, does not agree to abstain from contact lens use from day 0 through the last study drug dose
• History of intercurrent illness (cardiovascular, renal, hepatic, etc.) or laboratory abnormality that, in the investigator’s opinion would increase the risk of participating in the study or limit compliance with study requirements
• Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with TVB-2640; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to TVB-2640