Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Everolimus and OSI-906 for Patients With Refractory Metastatic Colorectal Cancer

This study has been completed.
Novartis Pharmaceuticals
OSI Pharmaceuticals
Information provided by (Responsible Party):
SCRI Development Innovations, LLC Identifier:
First received: June 29, 2010
Last updated: July 19, 2013
Last verified: July 2013

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.

Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: OSI-906
Drug: Everolimus
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • To determine the maximum tolerated dose of the combination of OSI-906 and everolimus for the treatment of patients with refractory metastatic colorectal cancer. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of the combination of OSI-906 and everolimus by measurement of progression-free survival (PFS), response rate (RR), and overall survival (OS) in the treatment of patients with refractory metastatic colorectal cancer. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: July 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OSI-906/Everolimus
combination of OSI-906 and everolimus
Drug: OSI-906
50 mg Twice a Day, cycle-28 days
Drug: Everolimus
5mg Daily, cycle-28 days


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 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 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01154335

United States, Florida
Florida Cancer Specialists
Ft. Myers, Florida, United States, 33916
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
SCRI Development Innovations, LLC
Novartis Pharmaceuticals
OSI Pharmaceuticals
Study Chair: Johanna Bendell, MD SCRI Development Innovations, LLC
  More Information

No publications provided

Responsible Party: SCRI Development Innovations, LLC Identifier: NCT01154335     History of Changes
Other Study ID Numbers: SCRI GI 124
Study First Received: June 29, 2010
Last Updated: July 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by SCRI Development Innovations, LLC:
refractory metastatic colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 20, 2014