An Open-label, Non-randomised Dose Escalation Study of KRN951 Administered Orally to Patients With Solid Tumors
Phase 1
20 Years
N/A
20 Years
N/A
Open (Enrolling)
Both
Solid Tumors
Both
Solid Tumors
Trial Information
An Open-label, Non-randomised Dose Escalation Study of KRN951 Administered Orally to Patients With Solid Tumors
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To define the maximum tolerated dose (MTD) of KRN-951 when administered orally for 21 days followed by a 7-day rest period.
Safety Issue:
Yes
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
KRN951-001
NCT ID:
NCT00970411
Start Date:
August 2009
Completion Date:
Related Keywords:
- Solid Tumors
- Neoplasms
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