A Study of the Safety and Effects of ADH-1 Given Intravenously as a Single Agent
- Conditions
- Neoplasms
- Registration Number
- NCT00264433
- Lead Sponsor
- Adherex Technologies, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
-
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
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Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and electrocardiogram (ECG)
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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
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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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
McGill University Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Lineberger Comprensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Centre for Clinical Research
🇨🇦Halifax, Nova Scotia, Canada
The Ottawa Hospital Regional Cancer Center (TOHRCC)
🇨🇦Ottawa, Ontario, Canada
Florida Cancer Specialist
🇺🇸Fort Myers, Florida, United States
Duke Comprehensive Cancer Centre
🇺🇸Durham, North Carolina, United States
Chattanooga Oncology and Hematology Associates
🇺🇸Chattanooga, Tennessee, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
BC Cancer Agency - Vancouver Centre
🇨🇦Vancouver, British Columbia, Canada