Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SCRI Development Innovations, LLC
With
Novartis Pharmaceuticals
OSI Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Metastatic cancer of the colon or rectum that has progressed on or for which the patient is intolerant to or not a candidate for: fluoropyrimidines, oxaliplatin, irinotecan, bevacizumab, and cetuximab or panitumumab.
Testing for Kras mutation performed;Patients with mutated or wild type Kras are eligible.
ECOG PS of 0-1
Life expectancy of ≥ 3 months
Adequate hematological function with ANC 1500, Platelets of 100,000, and hemoglobin of 9.0
AST, ALT and Alk. Phos. ≤2.5 x ULN or ≤5 x ULN if known hepatic metastases and a total bilirubin ≤1.5 ULN
Serum creatinine of ≤1.5 x ULN
Fasting blood glucose \<150 mg/dL
Measurable disease according to RECIST 1.1
Able to swallow whole pills
INR ≤1.5 - Anticoagulation is allowed with LMW heparin
Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤2.5 x ULN;If these thresholds are exceeded, the patient can be included after initiation of lipid lowering medication
You may not be if
Patients who have received any cancer therapies \<4 weeks or 5 half lives (whichever is shorter) of initiating study therapy
Treatment with any investigational drug ≤ 4 weeks, or 5 half-lives of the drug, whichever is shorter
Patients who require coumadin for anticoagulation
Patients who have had major surgery or significant traumatic injury ≤4 weeks of the of study treatment
Minor surgery (with the exception of port placement) must be completed ≤ 7days prior to study therapy
Previous treatment with an IGFR inhibitor or MTOR Inhibitor
Chronic, systemic treatment with corticosteroids or another immunosuppressive agent
Patients with QTc interval \>450ms
Patients who require drugs that can prolong QTc.
Patients with congenital long QT syndrome, history of ventricular tachycardia, or ventricular fibrillation, or Torsades de Pointes with bradycardia.
Immunization with attenuated live vaccines within 1 week of beginning study therapy or during study period;Close contact to anyone that has received live virus vaccine should be avoided
Meningeal or brain metastasis
Other malignancies \< 3 years, with the exception of adequately treated basal or squamous cell carcinomas of the skin, or carcinoma in situ of the cervix
Patients with known HIV
Patients with positive testing for hepatitis B or C
Patients with risk factors for hepatitis must be tested for hepatitis viral loadHepatitis risk factors include the following:
Lived in Asia, Africa, Central and South America, Eastern Europe, Spain, Portugal, and Greece Any blood transfusions before 1990 Any IV drug use Any dialysis Household contact with a Hep B infected patient Mother had Hep B High-risk sexual activity Body piercing/tattoos
History suggestive of hepatitis B
Any severe or uncontrolled conditions that could affect their study participation such as:Severely impaired lung function;DCLO ≤ 50% of normal predicted value;O² Sat \<88% at rest on room air
Congestive Heart Failure of NYHA Class III or IV
Unstable angina, symptomatic CHF, MI ≤ 6 months, serious uncontrolled cardiac arrhythmia or any other clinically significant heart disease
CVA, TIA, angioplasty, or cardiac stenting \<12 months
Ventricular arrhythmia requiring medication
Known history of diabetes and/or patients who require ongoing use of insulin or oral anti-hyperglycemic therapy
Known liver disease
Impairment of GI function or gastrointestinal disease that in may significantly alter the absorption of study drugs
Concurrent treatment with drugs that are strong CYP3A4 inducers or moderate/strong CYP3A4 inhibitors
Concurrent treatment with drugs that are strong CYP1A2 inhibitors or inducers Women who are pregnant or breastfeeding.
Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
