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

NCT ID: NCT00264433

Last Updated: 2007-08-06

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

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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

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Conditions

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Neoplasms

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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ADH -1 (Exherin™)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adherex Technologies, Inc.

INDUSTRY

Sponsor Role lead

Locations

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Florida Cancer Specialist

Fort Myers, Florida, United States

Site Status

Lineberger Comprensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status

Duke Comprehensive Cancer Centre

Durham, North Carolina, United States

Site Status

Chattanooga Oncology and Hematology Associates

Chattanooga, Tennessee, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

BC Cancer Agency - Vancouver Centre

Vancouver, British Columbia, Canada

Site Status

Centre for Clinical Research

Halifax, Nova Scotia, Canada

Site Status

The Ottawa Hospital Regional Cancer Center (TOHRCC)

Ottawa, Ontario, Canada

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

McGill University Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Related Links

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http://www.adherex.com

Adherex Technologies Inc. Corporate Homepage

Other Identifiers

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Adherex Protocol # AHX-01-201

Identifier Type: -

Identifier Source: org_study_id