Drug: |
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Trial Name: |
Safety Study to Evaluate KW-2450 in Subjects With Advanced Solid Tumor |
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NCT#: |
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Conditions: |
Solid Tumors |
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Status: |
Completed |
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Phase: |
1 |
Start Date 06/01/2009 |
Age of Trial (yrs) 14.8 |
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Treatment Phase: |
Gleevec-resistant |
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Drug Category: |
IGF1R inhibitor |
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Strategy: |
Block related tumor signal paths |
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Trial Type: |
GIST not specified. GIST patient enrollment unknown. |
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Other Protocol IDs: |
2450-US-001 |
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Sponsor: |
Kyowa Hakko Kirin Pharma, Inc. |
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Patient Contact: |
Danyel Davis
(609) 919-1100
ddavis@kyowa-kirin-pharma.com
Niranjan Rao
(609) 919-1100
nrao@kyowa-kirin-pharma.com
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Contact email: |
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Contact Phone: |
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Randomized: |
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IV or Oral: |
Oral |
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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 |
Name |
Address |
City |
State |
Zip |
Country |
Baltimore |
MD |
21201 |
USA |
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4100 John R |
Detroit |
MI |
48201 |
USA |
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1275 York Ave |
New York |
NY |
10065 |
USA |