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

Neoplasms Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264433
• Other study ID #: Adherex Protocol # AHX-01-201
• Status: Completed
• Phase: Phase 2
• First received: December 12, 2005
• Last updated: August 3, 2007

Study information

• Verified date: August 2007
• Source: Adherex Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• ADH -1 (Exherin™)

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Centre for Clinical Research	Halifax	Nova Scotia
Canada	McGill University Jewish General Hospital	Montreal	Quebec
Canada	The Ottawa Hospital Regional Cancer Center (TOHRCC)	Ottawa	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	BC Cancer Agency - Vancouver Centre	Vancouver	British Columbia
United States	Lineberger Comprensive Cancer Center	Chapel Hill	North Carolina
United States	Chattanooga Oncology and Hematology Associates	Chattanooga	Tennessee
United States	Duke Comprehensive Cancer Centre	Durham	North Carolina
United States	Florida Cancer Specialist	Fort Myers	Florida
United States	Sarah Cannon Research Institute	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Adherex Technologies, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

External Links

•   Adherex Technologies Inc. Corporate Homepage