NCT00199342

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

An Open-Label Study of KW-2871 Administered With a Premedication Regimen in Patients With Advanced Stage IV Melanoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Kyowa Kirin, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This open label study consists of two parts. Part I, the Phase I component of the study, will be conducted at a single center, and will enroll up to 18 patients with histologically documented Stage IV melanoma (per the American Joint Committee on Cancer \[AJCC\] criteria) that is not currently amenable to surgical resection or other therapies. A specified premedication regimen consisting of ranitidine, diphenhydramine, and dexamethasone will be administered to all patients 30 minutes prior to infusion of any dose of KW-2871. Planned doses of KW-2871 are 60 mg/m2, 80 mg/m2, 100 mg/m2 After identification of the MTD, 30 patients will be enrolled at that dose level in Part II of the study. If no MTD is identified after treatment with the 100 mg/m2 dose level, the dose administered in Part II of the study will be 100 mg/m2. If the MTD is determined as 60 mg/m2, this study will be closed to further patient accrual and will not proceed to Part II.

Conditions

• Stage IV Melanoma

Interventions

Type	Name	Description
DRUG	KW-2871	potentially therapeutic monoclonal antibody for the treatment of advanced stage four melanoma

Timeline

• Start date: 2004-11-01
• Primary completion: 2005-10-01
• First posted: 2005-09-20
• Last updated: 2024-05-03

Locations

2 sites across 1 country: United States