A Study of the Safety and Effects of ADH-1 Given Intravenously as a Single Agent

This study has been completed.
Sponsor:
Information provided by:
Adherex Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00264433
First received: December 12, 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 specific incurable, solid tumors with a protein biomarker called N-cadherin. This study will examine the clinical activity of ADH-1.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Phase 2a Study in Subjects With N-Cadherin Positive, Advanced or Recurrent Solid Tumors to Investigate the Safety and Efficacy of ADH-1 Administered Intravenously as a Single Agent (Adherex Protocol Number AHX-01-201)

Resource links provided by NLM:


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

  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
  • Histologically proven advanced and/or metastatic solid tumor of one of the following histologies:

    • non-small cell lung cancer (squamous or non-squamous histology),
    • gastroesophageal carcinoma (squamous or adenocarcinoma histology),
    • renal cell carcinoma,
    • hepatocellular carcinoma,
    • adrenocortical carcinoma
  • 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 spinal cord compression, or history of primary brain tumor(s) 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 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:

    • uncontrolled congestive heart failure,
    • coronary artery disease, or life threatening arrhythmias;
    • myocardial infarction less than 12 months prior to study entry;
    • significant 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: NCT00264433

Locations
United States, Florida
Florida Cancer Specialist
Fort Myers, Florida, United States, 33908
United States, North Carolina
Lineberger Comprensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Duke Comprehensive Cancer Centre
Durham, North Carolina, United States, 27703
United States, Tennessee
Chattanooga Oncology and Hematology Associates
Chattanooga, Tennessee, United States, 37404
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada
Canada, British Columbia
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Centre for Clinical Research
Halifax, Nova Scotia, Canada
Canada, Ontario
The Ottawa Hospital Regional Cancer Center (TOHRCC)
Ottawa, Ontario, Canada, K1H 1C4
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Adherex Technologies, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00264433     History of Changes
Other Study ID Numbers: Adherex Protocol # AHX-01-201
Study First Received: December 12, 2005
Last Updated: August 3, 2007
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; Esophageal Cancer; Gastric Cancer; Renal Cell Carcinoma; Hepatocellular Carcinoma; Adrenocortical Carcinoma

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 22, 2014