A Study of ADH 1 in Combination With Carboplatin, or Docetaxel or Capecitabine

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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 the combination ADH-1 and carboplatin or ADH-1 and docetaxel or ADH-1 and capecitabine in subjects with specific incurable, solid tumors with a protein biomarker called N-cadherin.

Key facts

Study ID

NCT00390676

Run by

Adherex Technologies, Inc.

Starts

2006-11-01

Expected to finish

2009-11-01

Last updated by the study team

2010-12-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed written informed consent
• Male and female patients > or = 18 years of age with a solid tumor(s) that is locally advanced or metastatic for which single agent carboplatin, or docetaxel or capecitabine would be appropriate
• Measurable disease
• Immunohistochemical evidence of N-cadherin expression in tumor tissue
• Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and ECG

You may not qualify if…

• Receipt of ADH-1 prior to this clinical study
• Chemotherapy, radiotherapy, or any other investigational drug within 4 weeks 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 within 12 weeks before study entry
• Stroke, major surgery, or other major tissue injury within 4 weeks before study entry
• Uncontrolled congestive heart failure, coronary artery disease, or life threatening arrhythmias; myocardial infarction within 12 months; significant electrocardiogram (ECG) abnormalities, or known hypercoagulable states

Where it is running

• Rocky Mountain Cancer Centers — Denver, Colorado, United States
• Cancer Centers of Florida — Ocoee, Florida, United States
• Central Indiana Cancer Centers — Indianapolis, Indiana, United States
• New York Oncology Hematology P.C. — Albany, New York, United States
• Dayton Oncology & Hematology, P.A — Kettering, Ohio, United States
• Cancer Centers of the Carolinas — Greenville, South Carolina, United States
• Texas Oncology, PA — Dallas, Texas, United States
• Tyler Cancer Center — Tyler, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Northwest Cancer Specialists - Vancouver Cancer Center — Vancouver, Washington, United States

Full record on ClinicalTrials.gov

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