A Study of ADH 1 in Combination With Carboplatin, or Docetaxel or Capecitabine
A Phase 1, Multicenter, Dose-Escalation Study to Investigate the Safety and Tolerability of ADH-1 in Combination With 1) Carboplatin or 2) Docetaxel or 3) Capecitabine in Subjects With N-Cadherin Positive, Advanced Solid Tumors (Adherex Protocol Number AHX-01-006)
1 other identifier
interventional
N/A
1 country
10
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2006
Typical duration for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2006
CompletedFirst Posted
Study publicly available on registry
October 20, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedDecember 28, 2010
December 1, 2010
October 18, 2006
December 27, 2010
Conditions
Keywords
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Adherex Technologies, Inc.lead
- US Oncology Researchcollaborator
Study Sites (10)
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Cancer Centers of Florida
Ocoee, Florida, 34761, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, 46219, United States
New York Oncology Hematology P.C.
Albany, New York, 12208, United States
Dayton Oncology & Hematology, P.A
Kettering, Ohio, 45409, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605, United States
Texas Oncology, PA
Dallas, Texas, 75246, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Northwest Cancer Specialists - Vancouver Cancer Center
Vancouver, Washington, 98684, United States
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 18, 2006
First Posted
October 20, 2006
Study Start
November 1, 2006
Study Completion
November 1, 2009
Last Updated
December 28, 2010
Record last verified: 2010-12