Study of ADH-1 Given Intravenously to Patients With Solid Tumors

NCT00265057 | Completed Phase 1

• 1 other identifier: Adherex Protocol # AHX-01-004
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 3

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 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.

Conditions

Neoplasms

Keywords

Cancer;; Tumors;; Neoplasms;; Anticarcinogenic Agents;; Antineoplastic Agents;; Cadherins;; Non-Small-Cell Lung Carcinoma;; Ovarian Cancer

Interventions

ADH -1 (Exherin™) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Adherex Technologies, Inc.: lead

Study Sites (3)

Istituto Nazionale per lo Studio e la Cura dei Tumori

Milan, 20133, Italy

Location

Instituto Europeo di Oncologia

Milan, 20141, Italy

Location

Istituto Oncologico della Svizzera Italiana

Bellinzona, 6500, Switzerland

Location

Related Links

• Adherex Technologies Inc. Corporate Homepage

MeSH Terms

Conditions

Neoplasms; Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms

Interventions

N-Ac-CHAVC-NH2

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 13, 2005
• First Posted: December 14, 2005
• Study Start: June 1, 2005
• Study Completion: January 1, 2008
• Last Updated: December 28, 2010

Record last verified: 2010-12

Locations

IT (2); CH (1)