- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00264433
A Study of the Safety and Effects of ADH-1 Given Intravenously as a Single Agent
August 3, 2007 updated by: Adherex Technologies, Inc.
An Open-Label Phase 2a Study in Subjects With N-Cadherin Positive, Advanced or Recurrent Solid Tumors to Investigate the Safety and Efficacy of ADH-1 Administered Intravenously as a Single Agent (Adherex Protocol Number AHX-01-201)
N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells.
ADH-1 blocks N-cadherin.
This study will test the safety and effects of ADH-1 in subjects with specific incurable, solid tumors with a protein biomarker called N-cadherin.
This study will examine the clinical activity of ADH-1.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Edmonton, Alberta, Canada
- Cross Cancer Institute
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British Columbia
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Vancouver, British Columbia, Canada
- BC Cancer Agency - Vancouver Centre
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Nova Scotia
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Halifax, Nova Scotia, Canada
- Centre for Clinical Research
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Ontario
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Ottawa, Ontario, Canada, K1H 1C4
- The Ottawa Hospital Regional Cancer Center (TOHRCC)
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
- McGill University Jewish General Hospital
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Florida
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Fort Myers, Florida, United States, 33908
- Florida Cancer Specialist
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Lineberger Comprensive Cancer Center
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Durham, North Carolina, United States, 27703
- Duke Comprehensive Cancer Centre
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Tennessee
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Chattanooga, Tennessee, United States, 37404
- Chattanooga Oncology and Hematology Associates
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Nashville, Tennessee, United States, 37203
- Sarah Cannon Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed written informed consent
- Male and female patients > or = 18 years of age with a solid tumor(s) refractory to standard curative therapy or for which no curative therapy exists
Histologically proven advanced and/or metastatic solid tumor of one of the following histologies:
- non-small cell lung cancer (squamous or non-squamous histology),
- gastroesophageal carcinoma (squamous or adenocarcinoma histology),
- renal cell carcinoma,
- hepatocellular carcinoma,
- adrenocortical carcinoma
- Measurable disease
- Immunohistochemical evidence of N-cadherin expression (at least 1+ positive) in archived or fresh tumor tissue
- Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and electrocardiogram (ECG)
Exclusion Criteria:
- Receipt of ADH-1 prior to this clinical study
- Chemotherapy, radiotherapy, or any other investigational drug within 30 days before study entry
- History of spinal cord compression, or history of primary brain tumor(s) or brain metastases (known or suspected) unless any lesions have completely resolved following appropriate treatment and there has been no recurrence for at least 6 months
- History of tumors that have shown clinically significant evidence of active bleeding (e.g., gross hemoptysis, hematemesis, hematuria, melena, or bleeding superficial tumor) within 12 weeks before study entry
- Stroke, major surgery, or other major tissue injury within 30 days before study entry
History of:
- uncontrolled congestive heart failure,
- coronary artery disease, or life threatening arrhythmias;
- myocardial infarction less than 12 months prior to study entry;
- significant ECG abnormalities; or
- known hypercoagulable states
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
December 12, 2005
First Submitted That Met QC Criteria
December 12, 2005
First Posted (Estimate)
December 13, 2005
Study Record Updates
Last Update Posted (Estimate)
August 6, 2007
Last Update Submitted That Met QC Criteria
August 3, 2007
Last Verified
August 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Adherex Protocol # AHX-01-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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