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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Up to 28 days
United States: Food and Drug Administration
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