Study of KRN951 in Patients With Solid Tumors

Kyowa Kirin

Status and phase

Completed

Phase 1

Conditions

Solid Tumors

Treatments

Drug: KRN951

Study type

Interventional

Funder types

Industry

Identifiers

NCT00970411

KRN951-001

Details and patient eligibility

About

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 of KRN951 in the first day, followed by a 6-day rest period during which no treatment is received. After that, patients in each cohort will receive one oral dose of KRN951 daily over a 21-day treatment period, followed by a 7-day rest period during which no treatment is received. Treatment will be continued in the absence of disease progression or unacceptable adverse events.

Enrollment

12 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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