A Phase I Study of EMD 121974 in Patients With Advanced Solid Tumors
I. Determine the toxic effects and maximum tolerated dose of EMD 121974 in patients with
advanced solid tumors.
II. Determine the biologic activity of this drug in these patients. III. Determine the
pharmacokinetic profile and plasma biological effects of this drug and identify any
relationship with its biologic activity or observed toxicity in these patients.
IV. Determine, preliminarily, the antitumor efficacy of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat every 4 weeks in the
absence of disease progression or unacceptable toxicity.
Cohorts of 3-10 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 6
patients experience dose-limiting toxicity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of cilengitide defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Graded according to the NCI Common Toxicity Criteria version 2.0.
University of Colorado, Denver
United States: Food and Drug Administration
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