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

Status:

COMPLETED

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

Lead Sponsor:

Adherex Technologies, Inc.

Conditions:

Neoplasms

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 ...

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00264433

Last Update

August 6 2007

Active Locations (11)

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Page 1 of 3 (11 locations)

Florida Cancer Specialist

Fort Myers, Florida, United States, 33908

Lineberger Comprensive Cancer Center

Chapel Hill, North Carolina, United States, 27599

Duke Comprehensive Cancer Centre

Durham, North Carolina, United States, 27703