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
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2009
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 31, 2009
CompletedFirst Posted
Study publicly available on registry
September 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedJanuary 5, 2017
January 1, 2017
6.7 years
August 31, 2009
January 3, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
To determine the pharmacokinetics of KRN951 in serum
To describe biological and clinical anti-tumor activity
Study Arms (1)
KRN951
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Shizuoka, Japan
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2009
First Posted
September 2, 2009
Study Start
August 1, 2009
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
January 5, 2017
Record last verified: 2017-01