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

This study has been terminated.
Sponsor:
Information provided by:
Adherex Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00225550
First received: September 22, 2005
Last updated: August 3, 2007
Last verified: August 2007
  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 Daily for 5 Consecutive Days by Intravenous Infusion in Subjects With N-Cadherin Expressing, Incurable, Solid Tumors (Adherex Protocol Number AHX 01 003)

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225550

Locations
United States, Texas
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Adherex Technologies, Inc.
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00225550     History of Changes
Other Study ID Numbers: Adherex Protocol AHX-01-003
Study First Received: September 22, 2005
Last Updated: August 3, 2007

Keywords provided by Adherex Technologies, Inc.:
Cancer;
Tumors;
Neoplasms;
Anticarcinogenic Agents;
Antineoplastic Agents;
Cadherins

ClinicalTrials.gov processed this record on March 24, 2017