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A Phase 1 Trial of CCI-779 in Combination With EKB-569, an EGFR Inhibitor, in Patients With Solid Tumors

Phase 1
18 Years
Not Enrolling
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase 1 Trial of CCI-779 in Combination With EKB-569, an EGFR Inhibitor, in Patients With Solid Tumors


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

- 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

- No other concurrent investigational agents

- No concurrent warfarin

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients

Outcome Time Frame:

Up to 28 days

Safety Issue:


Principal Investigator

Charles Erlichman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

October 2004

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms



Mayo Clinic Rochester, Minnesota  55905