drugset / Trial / NCT00199342

A Study of a Monoclonal Antibody, KW-2871, in Patients With Advanced Melanoma

NCT00199342 ↗

Phase 1/2 Terminated 5 enrolled Kyowa Kirin, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a dose escalating cohort study to determine the maximum tolerated dose (MTD) of KW-2871 (in dose cohorts of 60, 80, and 100 mg/m2) when administered with a specified premedication regimen (ranitidine, diphenhydramine, and dexamethasone). KW-2871 will be administered at 14-day intervals.

Timeline

Start
2004-11
Primary completion
2005-10
Completion
—

Outcome

Outcome not reported

Stopped: “Occurrence of 2 dose-limiting toxicities at the initial dose level (60 mg/m2) in Part I.”

Drugs

EvaluationDrugModalityDoseRoute
Subject ECROMEXIMAB Monoclonal antibody 60 mg/m2 Intravenous
Subject ECROMEXIMAB Monoclonal antibody 80 mg/m2 Intravenous
Subject ECROMEXIMAB Monoclonal antibody 100 mg/m2 Intravenous

Indications