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Everolimus and Imatinib Mesylate in Treating Patients With Metastatic or Unresectable Kidney Cancer

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: NCT00331409
Recruitment Status : Completed
First Posted : May 31, 2006
Results First Posted : October 5, 2011
Last Update Posted : October 26, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Christopher Ryan, OHSU Knight Cancer Institute

Brief Summary:

RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Everolimus may also block blood flow to the tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving everolimus together with imatinib mesylate works in treating patients with metastatic or unresectable kidney cancer.

Condition or disease Intervention/treatment Phase
Kidney Cancer Drug: Everolimus Drug: imatinib mesylate Phase 2

Detailed Description:



  • Estimate the proportion of patients with previously treated metastatic or unresectable clear cell carcinoma of the kidney who are progression free (complete response [CR], partial response [PR], or stable disease [SD]) at 3 months after treatment with everolimus and imatinib mesylate.


  • Estimate median time to progression in patients treated with this regimen.
  • Determine the proportion of patients whose best overall response are CR, PR, SD, or progressive disease.
  • Evaluate the mean and range of the maximum percent reduction in tumor size.
  • Describe the toxicities of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral imatinib mesylate and oral everolimus once daily beginning on day 1 and continuing in the absence of disease progression.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of the Mammalian Target of Rapamycin (mTOR) Inhibitor RAD001 in Combination With Imatinib Mesylate in Patients With Previously Treated Advanced Renal Carcinoma
Study Start Date : January 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Experimental: Everolimus and Imatinib Mesylate
Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
Drug: Everolimus
2.5 mg by mouth daily
Other Names:
  • Afinitor
  • RAD001
  • Certican

Drug: imatinib mesylate
600 mg by mouth daily
Other Names:
  • Gleevec
  • STI-571

Primary Outcome Measures :
  1. Progression-free Survival at 3 Months [ Time Frame: 3 months post 1st dose ]
  2. Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  1. Median Time to Progression [ Time Frame: Time to progression ]
  2. Number of Subjects That Demonstrated a Reduction in Tumor Measurements. [ Time Frame: Up to 4 years ]
    Number of subjects that received at least one post-baseline scan that demonstrated a reduction in sum target lesions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

  3. Number of Participants With Adverse Events [ Time Frame: Duration of study, Up to 4 years ]

    Toxicity assessments will be obtained as follows:

    Cycle 1: Weeks 1,2,3 Cycle 2: Weeks 6,9 Cycle 3: Weeks 12, 15 Cycle 4: Weeks 18, 21 Cycle 5: Weeks 24, 27 Cycle 6+: Every visit during these cycles

    Safety assessments will consist of evaluating adverse events and serious adverse events.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed clear cell kidney cancer, meeting 1 of the following criteria:

    • Measurable metastatic disease
    • Locally unresectable disease
  • No history of known brain metastases that have not been adequately treated with radiotherapy and/or surgery
  • Must have received ≥ 1 prior systemic therapy for metastatic or unresectable renal cell carcinoma


  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Absolute neutrophil count > 1,500/mm³
  • Platelet count > 100,000/mm³
  • Hemoglobin > 8 g/dL
  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • Serum glutamic oxaloacetic transaminase(SGOT) and Serum glutamic pyruvic transaminase(SGPT) < 2.5 times ULN
  • Creatinine < 1.5 times ULN
  • No New York Heat Association grade III-IV cardiac disease
  • No other malignancy within the past 5 years except basal cell skin cancer, cervical carcinoma in situ, or insignificant or inactive disease
  • No chronic liver disease (i.e., chronic active hepatitis or cirrhosis)
  • No severe or uncontrolled medical disease
  • No gastrointestinal disease or impairment that would hinder the absorption of everolimus
  • No uncontrolled diabetes
  • No chronic renal disease
  • No active uncontrolled infection
  • No congestive heart failure
  • No myocardial infarction within the past 6 months


  • See Disease Characteristics
  • More than 2 weeks since prior major surgery
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin C)
  • More than 4 weeks since prior immunotherapy
  • More than 4 weeks since other prior investigational agents
  • No prior radiotherapy to > 25% of bone marrow
  • No prior treatment with an mammalian target of rapamycin(mTOR) inhibitor
  • No concurrent therapeutic warfarin

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): NCT00331409

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United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
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Study Chair: Christopher W. Ryan, MD OHSU Knight Cancer Institute

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Responsible Party: Christopher Ryan, Principal Investigator, OHSU Knight Cancer Institute Identifier: NCT00331409     History of Changes
Other Study ID Numbers: IRB00001754
OHSU-SOL-05108-LM ( Other Identifier: OHSU Knight Cancer Institute )
FWA00000161 ( Other Identifier: OHSU IRB )
OHSU-1754 ( Other Identifier: OHSU IRB )
CDR0000479150 ( Other Identifier: NCI PDQ )
First Posted: May 31, 2006    Key Record Dates
Results First Posted: October 5, 2011
Last Update Posted: October 26, 2017
Last Verified: September 2017
Keywords provided by Christopher Ryan, OHSU Knight Cancer Institute:
stage III renal cell cancer
stage IV renal cell cancer
clear cell renal cell carcinoma
recurrent renal cell cancer
Additional relevant MeSH terms:
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Protein Kinase Inhibitors
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Imatinib Mesylate
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action