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

This study has been completed.
Sponsor:
Information provided by:
Adherex Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00265057
First received: December 13, 2005
Last updated: December 27, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Neoplasms
Drug: ADH -1 (Exherin™)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Adherex Technologies, Inc.:

Study Start Date: June 2005
Study Completion Date: January 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265057

Locations
Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milan, Italy, 20133
Instituto Europeo di Oncologia
Milan, Italy, 20141
Switzerland
Istituto Oncologico della Svizzera Italiana
Bellinzona, Switzerland, 6500
Sponsors and Collaborators
Adherex Technologies, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00265057     History of Changes
Other Study ID Numbers: Adherex Protocol # AHX-01-004
Study First Received: December 13, 2005
Last Updated: December 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Adherex Technologies, Inc.:
Cancer;
Tumors;
Neoplasms;
Anticarcinogenic Agents;
Antineoplastic Agents;
Cadherins;
Non-Small-Cell Lung Carcinoma;
Ovarian Cancer

Additional relevant MeSH terms:
Neoplasms
Antineoplastic Agents
Anticarcinogenic Agents
Therapeutic Uses
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 14, 2014