NCT00921336

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

Open-Label, Sequential, Ascending, Multi-Dose, Phase 1 Study of KW-2450 as Monotherapy in Subjects With Previously Treated Advanced Solid Tumor

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will determine the maximum dose of KW-2450 that can be administered safely to subjects with advanced previously treated solid tumor and evaluate its effectiveness.

Detailed description

This open-label, sequential, ascending, multi-dose, Phase 1 study will enroll up to 72 subjects with previously treated advanced solid tumor. Subjects at each dose level will receive KW-2450 orally, once daily for 28 days followed by a 1-week observation period. After completing the 1 week observation period, all subjects will receive KW-2450 on a continuous daily schedule. All doses of KW-2450 will be administered to subjects under overnight fasting conditions. 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 titration. 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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-06-16
• Last updated: 2024-04-25

Locations

3 sites across 1 country: United States