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A Phase I Study of Everolimus (mTOR Inhibitor) and OSI-906 (Dual IGFR and IR Tyrosine Kinase Inhibitor) for the Treatment of Patients With Refractory Metastatic Colorectal Cancer

Phase 1
18 Years
Open (Enrolling)
Metastatic Colorectal Cancer

Thank you

Trial Information

A Phase I Study of Everolimus (mTOR Inhibitor) and OSI-906 (Dual IGFR and IR Tyrosine Kinase Inhibitor) for the Treatment of Patients With Refractory Metastatic Colorectal Cancer

Inclusion Criteria:

- 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

- 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 Criteria:

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose of the combination of OSI-906 and everolimus for the treatment of patients with refractory metastatic colorectal cancer.

Outcome Time Frame:

18 Months

Safety Issue:


Principal Investigator

Johanna Bendell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

July 2013

Related Keywords:

  • Metastatic Colorectal Cancer
  • refractory metastatic colorectal cancer
  • Colorectal Neoplasms



Florida Cancer SpecialistsFort Myers, Florida  33901
Tennessee OncologyNashville, Tennessee  37203