A Phase I Study Of Continuous Infusion EMD 121974 In Patients With Solid Tumors
I. Determine the dose-limiting toxicity, maximum feasible dose, and recommended phase II
dose of cilengitide (EMD 121974) in patients with advanced solid tumors or lymphoma.
II. Determine the safety and tolerability of this drug in these patients.
I. Determine the pharmacokinetics of this drug in these patients. II. Determine the
antineoplastic activity of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive cilengitide (EMD 121974) IV continuously on weeks 1-4. Courses repeat every
4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
patients receive escalating doses of EMD 121974 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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum feasible dose defined as the highest dose studied for which the incidence of DLT is less than 33% or the highest safe dose in our study, limited to a maximum MFD dose of 40 mg/hr
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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