Study of ADH-1 Given Intravenously to Patients 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 Weekly in 3 Week Cycles by Intravenous Infusion in Patients With N-Cadherin Expressing, Incurable, Solid Tumors (Adherex Protocol Number AHX-01-004)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265057
• Other study ID #: Adherex Protocol # AHX-01-004
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 13, 2005
• Last updated: December 27, 2010
• Start date: June 2005
• Est. completion date: January 2008

Study information

• Verified date: December 2010
• 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: Completed
• Enrollment: 0
• Est. completion date: January 2008
• 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. Study currently enrolling only patients with non-small cell lung cancer or advanced ovarian cancer to the safety expansion phase.

• 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 (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 spinal cord compression. 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 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
Italy	Instituto Europeo di Oncologia	Milan
Italy	Istituto Nazionale per lo Studio e la Cura dei Tumori	Milan
Switzerland	Istituto Oncologico della Svizzera Italiana	Bellinzona

Sponsors (1)

Lead Sponsor	Collaborator
Adherex Technologies, Inc.

Countries where clinical trial is conducted

Italy,  Switzerland, 

External Links

•   Adherex Technologies Inc. Corporate Homepage