TRIAL DETAIL

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

Drug:
Trial Name:
Safety Study to Evaluate KW-2450 in Subjects With Advanced Solid Tumor
NCT#:
Conditions:
Solid Tumors
Status:
Completed
Phase:
1
Start Date 06/01/2009
Age of Trial (yrs) 14.8
Treatment Phase:
Gleevec-resistant
Drug Category:
IGF1R inhibitor
Strategy:
Block related tumor signal paths
Trial Type:
GIST not specified. GIST patient enrollment unknown.
Other Protocol IDs:
2450-US-001
Sponsor:
Kyowa Hakko Kirin Pharma, Inc.
Patient Contact:
Danyel Davis (609) 919-1100 ddavis@kyowa-kirin-pharma.com Niranjan Rao (609) 919-1100 nrao@kyowa-kirin-pharma.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
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.

Trial Links

Trial Results

Drug Information

Phase 1 trial of KW-2450 at MSKCC
 

Trial Sites

Name
Address
City
State
Zip
Country
Baltimore
MD
21201
USA
4100 John R
Detroit
MI
48201
USA
1275 York Ave
New York
NY
10065
USA