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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00225550
Recruitment Status : Terminated
First Posted : September 26, 2005
Last Update Posted : August 6, 2007
Sponsor:
Information provided by:
Adherex Technologies, Inc.

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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: ADH -1 (Exherin™) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225550


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

Additional Information:
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ClinicalTrials.gov Identifier: NCT00225550    
Other Study ID Numbers: Adherex Protocol AHX-01-003
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: August 6, 2007
Last Verified: August 2007
Keywords provided by Adherex Technologies, Inc.:
Cancer;
Tumors;
Neoplasms;
Anticarcinogenic Agents;
Antineoplastic Agents;
Cadherins
Additional relevant MeSH terms:
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Neoplasms