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A Study of the Safety and Effects of ADH-1 Given Intravenously as a Single Agent | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of the Safety and Effects of ADH-1 Given Intravenously as a Single Agent

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)

NCT00264433•Adherex Technologies, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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
+1 more criteria

Locations (11)

Florida Cancer Specialist

Fort Myers, Florida, United States

Lineberger Comprensive Cancer Center

Chapel Hill, North Carolina, 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

Cross Cancer Institute

Edmonton, Alberta, Canada

BC Cancer Agency - Vancouver Centre

Vancouver, British Columbia, Canada

Centre for Clinical Research

Halifax, Nova Scotia, Canada

The Ottawa Hospital Regional Cancer Center (TOHRCC)

Ottawa, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Key Dates

Last Updated

August 6, 2007

Conditions

Neoplasms

Interventions

ADH -1 (Exherin™)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2007Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of the Safety and Effects of ADH-1 Given Intravenously as a Single Agent

Inclusion Criteria

Exclusion Criteria

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