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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

Phase 2
18 Years
Not Enrolling
Kidney Cancer

Thank you

Trial Information

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



- 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.

Inclusion Criteria


- Histologically confirmed clear cell kidney cancer, meeting 1 of the following

- 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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival at 3 Months

Outcome Time Frame:

3 months post 1st dose

Safety Issue:


Principal Investigator

Christopher W. Ryan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

OHSU Knight Cancer Institute


United States: Federal Government

Study ID:




Start Date:

January 2006

Completion Date:

January 2010

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • clear cell renal cell carcinoma
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



OHSU Knight Cancer Institute Portland, Oregon  97239