Expired Study
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Rochester, Minnesota 55905


This phase I trial is studying the side effects, best way to give, and best dose of CCI-779 and EKB-569 in treating patients with advanced solid tumors. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. EKB-569 may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Giving CCI-779 together with EKB-569 may kill more tumor cells.

Study summary:

OBJECTIVES: I. Determine the maximum tolerated dose of the combination of CCI-779 and EKB-569 in patients with advanced solid tumors. II. Determine the toxicity of this regimen in these patients. III. Determine the response rate in patients treated with this regimen. OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 3 treatment groups. Group I: Patients receive oral EKB-569 on days 1-28 and oral CCI-779 on days 1-7 and 15-21. Cohorts of 3-6 patients receive escalating doses of EKB-569 and CCI-779 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Group II: Patients receive oral EKB-569 at the MTD on days 4-28 of course 1 and days 1-28 of all subsequent courses and CCI-779 at the MTD on days 1-3 and 15-17. Group III: Patients receive EKB-569 at the MTD as in group I and oral CCI-779 at the MTD on days 7-9 and 19-21 of course 1 and days 1-3 and 15-17 of all subsequent courses. In all groups, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 30-42 patients (18-30 for group I, 6 for group II, and 6 for group III) will be accrued for this study within 1.35-1.75 years.


Inclusion Criteria: - Histologically confirmed unresectable solid tumor for which there is no known standard therapy that is potentially curative or capable of extending life expectancy - No CNS metastases - Performance status - ECOG 0-2 - At least 12 weeks - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 10 g/dL - Bilirubin normal - AST ≤ 3 times upper limit of normal (ULN) (5 times ULN if liver involvement) - Creatinine ≤ 1.5 times ULN - No New York Heart Association class III or IV heart disease - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation - Fasting cholesterol < 350 mg/dL - Fasting triglycerides < 400 mg/dL - No uncontrolled infection - No seizure disorder - More than 4 weeks since prior immunotherapy - More than 4 weeks since prior biologic therapy - No concurrent immunotherapy - No concurrent prophylactic colony-stimulating factor therapy - More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered - No other concurrent chemotherapy - No concurrent oral contraceptives - More than 4 weeks since prior radiotherapy - No prior radiotherapy to > 30% of bone marrow - No concurrent radiotherapy - More than 7 days since prior CYP3A4 inducers - No prior mTOR-targeting agents - No prior epidermal growth factor receptor-targeting agents - No concurrent antiretroviral therapy that induces or inhibits CYP3A4 for HIV-positive patients - No other concurrent investigational agents - No concurrent warfarin



Primary Contact:

Principal Investigator
Charles Erlichman
Mayo Clinic

Backup Contact:


Location Contact:

Rochester, Minnesota 55905
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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