Safety Study to Evaluate KW-2450 in Subjects With Advanced Solid Tumor

PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2010

Conditions
Solid Tumor
Interventions
DRUG

KW-2450

Dose escalation may proceed once \>= 3 subjects have completed the Day 29 blood sample to evaluate glucose. The safety of each dose level will be established prior to enrollment of subjects in the next dose level. Dose escalation will proceed sequentially with accelerated escalation. Once the criteria for completing the accelerated titration are reached, dose escalation will follow a modified Fibonacci schedule. Up to 6 subjects will be enrolled at each dose level. Enrollment will proceed until the maximum tolerated dose (MTD) has been established or the highest dose level (800 mg/day) has been reached. The Sponsor will enroll up to 12 additional subjects, in an expanded safety cohort.

Trial Locations (3)

10021

Memorial Sloan Kettering, New York

48201

Karmanos Cancer Institute, Detroit

21201-1595

University of Maryland Greenbaum Cancer Center, Baltimore

Sponsors
All Listed Sponsors
collaborator

Kyowa Hakko Kirin Pharma, Inc.

INDUSTRY

lead

Kyowa Kirin Co., Ltd.

INDUSTRY

NCT00921336 - Safety Study to Evaluate KW-2450 in Subjects With Advanced Solid Tumor | Biotech Hunter | Biotech Hunter