Status:
COMPLETED
Study of KRN951 in Patients With Solid Tumors
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Solid Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety and tolerability of KRN951 administered to patients with solid tumors. In the single dose period, patients in each cohort will receive one oral dose o...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Solid tumors to be unresponsive to, or untreatable by standard therapies
- ≥ three-month life expectancy
- Eastern Cooperative Oncology Group Performance Status score of 0, 1 or 2
Exclusion
- Hematologic abnormality
- Myocardial infarction or clinically symptomatic left ventricular failure
- Active hypertension or controllable hypertension more than 3 antihypertensive medications
- Symptomatic CNS metastasis
- Unhealed wounds
- Active infections
- Hepatic or renal functional disorder
- Any of the HBs antigen, HCV antibody and HIV antibody positivity
- Prior use of any chemotherapy, radiotherapy, immunotherapy or surgery within four weeks previous to first dose of study drug
- Pregnant or lactating women
- Women of childbearing potential and fertile men, unless willing to use adequate contraceptive protection
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00970411
Start Date
August 1 2009
End Date
April 1 2016
Last Update
January 5 2017
Active Locations (1)
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1
Shizuoka, Japan