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Completed

NCT Number: NCT00575562

Phase I Study of KRN330 Monoclonal Antibody in Patients With Colorectal Cancer

The primary objective of this study is to assess the safety and tolerability of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sarah Cannon Research Institute, Nashville, Tennessee, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Have histologically confirmed colorectal cancer that is advanced or metastatic with measurable or assessable disease.
  • Are not candidates for a surgically curative procedure.
  • Have progressed despite, are intolerant of, or are not appropriate for current therapies.

Exclusion criteria

  • Have an active, uncontrolled infection.
  • Have known or suspected cerebral metastasis.
  • Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 6 months; or meet the criteria for AHA class III or IV congestive heart failure (CHF).
  • Have any significant concurrent disease or illness that would interfere with the interpretation of study results.
  • Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.

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Treatment and study plan

KRN330

Drug

Open-label, dose-escalation study of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer

Primary outcomes

  1. The primary objective of this study is to assess the safety and tolerability of KRN330 in patients with relapsed or refractory advanced or metastatic colorectal cancer.

    Time frame: For up to12 weeks

Secondary outcomes

  1. The secondary objectives are to determine the degree of immunogenicity, gain information on the pharmacokinetic profile, assess the anti-tumor effects of KRN330 and determine the maximum tolerated dose (MTD).

    Time frame: For up to12 weeks

Sponsors and collaborators

Lead sponsor

Kyowa Kirin, Inc.

Industry

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 18, 2007
Registry last updated
Apr 29, 2024

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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