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

NCT ID: NCT00575562

Last Updated: 2024-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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KRN330

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Have an active, uncontrolled infection.
2. Have known or suspected cerebral metastasis.
3. 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).
4. Have any significant concurrent disease or illness that would interfere with the interpretation of study results.
5. 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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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyowa Kirin, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jordan Berlin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ingram Professor of Cancer Research, Vanderbilt University

Howard A Burris, III, M.D.

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Locations

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Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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KRN330-US-01

Identifier Type: -

Identifier Source: org_study_id

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