Study of KRN951 in Patients With Solid Tumors

An Open-label, Non-randomised Dose Escalation Study of KRN951 Administered Orally to Patients With Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00970411

Enrollment

Registered

2009-09-02

Start date

2009-08-31

Completion date

2016-04-30

Last updated

2017-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

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.

Interventions

DRUGKRN951

Orally once daily administration

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To determine the pharmacokinetics of KRN951 in serum	—
To describe biological and clinical anti-tumor activity	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026