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Study of KRN951 in Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT00970411
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko 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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: KRN951 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Non-randomised Dose Escalation Study of KRN951 Administered Orally to Patients With Solid Tumors
Study Start Date : August 2009
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: KRN951 Drug: KRN951
Orally once daily administration




Primary Outcome Measures :
  1. To define the maximum tolerated dose (MTD) of KRN-951 when administered orally for 21 days followed by a 7-day rest period.
  2. 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 :
  1. To determine the pharmacokinetics of KRN951 in serum
  2. To describe biological and clinical anti-tumor activity


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970411


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

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT00970411     History of Changes
Other Study ID Numbers: KRN951-001
First Posted: September 2, 2009    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: January 2017