A Study of the Safety and Effects of ADH-1 Given Daily to Subjects With Solid Tumors - Full Text View

Purpose

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 incurable, solid tumors with a protein biomarker called N-cadherin. This study will identify the amount of ADH-1 that subjects can tolerate.

Condition	Intervention	Phase
Neoplasms	Drug: ADH -1 (Exherin™)	Phase I Phase II

MedlinePlus related topics:

Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment

Official Title:	Dose Finding, Safety, Pharmacokinetic and Pharmacodynamic Study of the Vascular Targeting Agent Exherin™ (ADH-1) Administered Once Daily for 5 Consecutive Days by Intravenous Infusion in Subjects With N-Cadherin Expressing, Incurable, Solid Tumors (Adherex Protocol Number AHX 01 003)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
Clinically or radiologically documented 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 primary brain tumors or brain metastases
History of spinal cord compression or tumors that have shown any evidence of active bleeding within 30 days before study entry.
Stroke, major surgery, or other major tissue injury within 30 days before study entry
History of congestive heart failure, myocardial infarction, angina, life threatening arrhythmias, significant electrocardiogram (ECG) abnormalities, or known hypercoagulable states

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225550

Locations


United States, Texas
	University of Texas M.D. Anderson Cancer Center
	Houston, Texas, United States, 77030

Sponsors and Collaborators

Adherex Technologies, Inc.

More Information

Adherex Technologies Inc. Corporate Homepage This link exits the ClinicalTrials.gov site

Study ID Numbers:	Adherex Protocol AHX-01-003
First Received:	September 22, 2005
Last Updated:	August 3, 2007
ClinicalTrials.gov Identifier:	NCT00225550
Health Authority:	United States: Food and Drug Administration

Keywords provided by Adherex Technologies, Inc.:

Cancer;

Tumors;

Neoplasms;

Anticarcinogenic Agents;

Antineoplastic Agents;

Cadherins

Study placed in the following topic categories:

Signs and Symptoms

Additional relevant MeSH terms:

Neoplasms

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Adherex Technologies, Inc.
Information provided by:	Adherex Technologies, Inc.
ClinicalTrials.gov Identifier:	NCT00225550