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

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)

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: ADH -1 (Exherin™)

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20133
    • Istituto Nazionale per lo Studio e la Cura dei Tumori
  • Milan, Italy, 20141
    • Instituto Europeo di Oncologia
• Switzerland
  • Bellinzona, Switzerland, 6500
    • Istituto oncologico della Svizzera italiana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Collaborators and Investigators

• Sponsor: Adherex Technologies, Inc.

Publications and helpful links

Helpful Links

• Adherex Technologies Inc. Corporate Homepage

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Study Completion (ACTUAL): January 1, 2008

Study Registration Dates

• First Submitted: December 13, 2005
• First Submitted That Met QC Criteria: December 13, 2005
• First Posted (ESTIMATE): December 14, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): December 28, 2010
• Last Update Submitted That Met QC Criteria: December 27, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Ovarian Cancer; Cancer;; Tumors;; Neoplasms;; Anticarcinogenic Agents;; Antineoplastic Agents;; Cadherins;; Non-Small-Cell Lung Carcinoma
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: Adherex Protocol # AHX-01-004