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

Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00225550
• Other study ID #: Adherex Protocol AHX-01-003
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 22, 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 incurable, solid tumors with a protein biomarker called N-cadherin. This study will identify the amount of ADH-1 that subjects can tolerate.

Recruitment information / eligibility

• Status: Terminated
• 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

• 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

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

Sponsors (1)

Lead Sponsor	Collaborator
Adherex Technologies, Inc.

Country where clinical trial is conducted

United States, 

External Links

•   Adherex Technologies Inc. Corporate Homepage