Study of KRN951 in Patients With Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Drug: KRN951

• Registration Number: NCT00970411
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-09-01
• Study First Posted: 2009-09-02
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KRN951	KRN951	-

Primary Outcome Measures

Name	Time	Method
To evaluate the safety profile and the tolerability of KRN951 throughout the study period by assessing adverse events and laboratory values recorded during treatment.
To define the maximum tolerated dose (MTD) of KRN-951 when administered orally for 21 days followed by a 7-day rest period.

Secondary Outcome Measures

Name	Time	Method
To determine the pharmacokinetics of KRN951 in serum
To describe biological and clinical anti-tumor activity