Status:
COMPLETED
A Study of ADH 1 in Combination With Carboplatin, or Docetaxel or Capecitabine
Lead Sponsor:
Adherex Technologies, Inc.
Collaborating Sponsors:
US Oncology Research
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
End Date :
November 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00390676
Start Date
November 1 2006
End Date
November 1 2009
Last Update
December 28 2010
Active Locations (10)
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1
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
2
Cancer Centers of Florida
Ocoee, Florida, United States, 34761
3
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
4
New York Oncology Hematology P.C.
Albany, New York, United States, 12208