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Completed

NCT Number: NCT00970411

Study of KRN951 in Patients With Solid Tumors

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.

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Key information

Conditions

Solid Tumors

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shizuoka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KRN951

Drug

Orally once daily administration

Primary outcomes

  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 outcomes

  1. To determine the pharmacokinetics of KRN951 in serum

  2. To describe biological and clinical anti-tumor activity

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Sep 2, 2009
Registry last updated
Jan 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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