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Interaction Study of Rapamycin and Sunitinib in Patients With Advanced Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00583063
Recruitment Status : Completed
First Posted : December 31, 2007
Last Update Posted : June 12, 2013
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
Determine the pharmacokinetic interactions between rapamycin and sunitinib in patients with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: sunitinib Drug: rapamycin Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Interaction Study of Rapamycin (Sirolimus) and SU11248 (Sunitinib) in Patients With Advanced Solid Tumors
Study Start Date : October 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: A
Sunitinib taken by mouth every day. Rapamycin (taken by mouth) will be started on Day 15 and then taken every day. Drugs can be taken until disease progression.
Drug: sunitinib
25 mg daily (oral dosing)
Other Name: Sutent

Drug: rapamycin
4 mg daily (oral dosing)
Other Name: Rapamune

Experimental: B
Rapamycin taken by mouth every day. Sunitinib (taken by mouth) will be started on Day 15 and then taken every day. Drugs can be taken until disease progression.
Drug: sunitinib
25 mg daily (oral dosing)
Other Name: Sutent

Drug: rapamycin
4 mg daily (oral dosing)
Other Name: Rapamune

Primary Outcome Measures :
  1. Pharmacokinetic interactions [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Toxicity of the combined drug regimen [ Time Frame: 4 weeks ]
  2. Response to drug regimen [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Metastatic or unresectable cancer for which standard treatments do not exist or are no longer effective or cancers where evidence of efficacy of single agent sunitinib or single agent mTOR inhibitor has been demonstrated
  • Measurable or non-measurable disease.
  • No prior treatments for 4 weeks before starting study
  • No ongoing toxicities from previous treatments
  • 18 years or older
  • Performance status 2 or better
  • Life expectancy of at least 3 months.
  • Normal organ and marrow function as defined below:

    • No transfusions of packed red blood cells within 1 week of starting treatment. A hemoglobin of 9.0 g/dL or greater is recommended. Patients should not be transfused for protocol participation.
    • Leukocytes greater than or equal to 3,000/μL
    • Absolute neutrophil count greater than or equal to 1,500/μL
    • Platelets greater than or equal to 100,000/μL
    • Total bilirubin less than or equal to 1.5 x ULN
    • AST and ALT less than or equal to 2.5x ULN (less than or equal to 5x ULN if liver function abnormalities are due to underlying disease)
    • Creatinine within normal institutional limits OR
    • Creatinine clearance > 60 mL/min/1.73 m2
    • PT or INR within normal institutional limits
    • Serum calcium within normal institutional limits
  • QTc < 500 msec.
  • Patients with prior anthracycline exposure or that have received central thoracic radiation must have NYHA class I cardiac function
  • Must agree to use adequate birth control
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Prior treatments within 4 weeks (6 weeks for nitrosoureas or mitomycin C) of entering the study or those who have not recovered from adverse events due prior treatments
  • Current treatment with other investigational agents.
  • Prior therapy with a VEGFR or mTOR inhibitor
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to rapamycin or sunitinib.
  • QTc prolongation (QTc interval equal to or greater than 500 msec) or other significant ECG abnormalities
  • Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients with any of the following conditions are excluded:

    • Serious or non-healing wound, ulcer, or bone fracture.
    • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment.
    • Known active infection
    • Major surgery or radiation therapy within 4 weeks of starting the study treatment.
    • NCI CTCAE Version 3.0 grade 3 hemorrhage within 4 weeks of starting the study treatment.
    • History of CVA or transient ischemic attack within 12 months prior to study entry.
    • History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to study entry.
    • History of pulmonary embolism within the past 12 months.
    • Class III or IV heart failure as defined by the NYHA functional classification system
    • Ongoing cardiac dysrhythmias
    • Poorly controlled hypertension (systolic blood pressure of 140 mmHg or higher or diastolic blood pressure of 90 mmHg or higher)
    • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
    • History of interstitial lung disease
  • Patients with severe immunodeficient states (as judged by the treating physician)
  • Pregnancy or breastfeeding.
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for interactions with the study drugs
  • Use of certain medications (as determined by the investigator)
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk or interfere with the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00583063

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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Ezra Cohen, MD University of Chicago
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Responsible Party: University of Chicago Identifier: NCT00583063    
Other Study ID Numbers: 15328B
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: March 2011
Additional relevant MeSH terms:
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Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors