Study of KRN951 in Patients With Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier:
NCT00970411
First received: August 31, 2009
Last updated: January 3, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Solid Tumors
Drug: KRN951
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Non-randomised Dose Escalation Study of KRN951 Administered Orally to Patients With Solid Tumors

Further study details as provided by Kyowa Hakko Kirin Co., Ltd:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To determine the pharmacokinetics of KRN951 in serum
  • To describe biological and clinical anti-tumor activity

Estimated Enrollment: 12
Study Start Date: August 2009
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KRN951 Drug: KRN951
Orally once daily administration

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970411

Locations
Japan
Shizuoka, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd
  More Information

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT00970411     History of Changes
Other Study ID Numbers: KRN951-001 
Study First Received: August 31, 2009
Last Updated: January 3, 2017

ClinicalTrials.gov processed this record on January 19, 2017