Status:
COMPLETED
Everolimus and OSI-906 for Patients With Refractory Metastatic Colorectal Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Novartis Pharmaceuticals
OSI Pharmaceuticals
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the maximum tolerated dose (MTD) of the combination of OSI-906 and everolimus for the treatment of patients with refractory metastatic colorectal cancer.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01154335
Start Date
July 1 2010
End Date
May 1 2013
Last Update
May 3 2022
Active Locations (2)
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1
Florida Cancer Specialists
Fort Myers, Florida, United States, 33916
2
Tennessee Oncology
Nashville, Tennessee, United States, 37203