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

This study has been completed.

Sponsor:

Collaborator:

US Oncology Research

Information provided by:

Adherex Technologies, Inc.

ClinicalTrials.gov Identifier:

NCT00390676

First received: October 18, 2006

Last updated: December 27, 2010

Last verified: December 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	October 18, 2006
Last Updated Date	December 27, 2010
Start Date ^ICMJE	November 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00390676 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of ADH 1 in Combination With Carboplatin, or Docetaxel or Capecitabine
Official Title ^ICMJE	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)
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Neoplasms
Intervention ^ICMJE	Drug: ADH -1 and carboplatin Drug: ADH -1 and docetaxel Drug: ADH -1 and capecitabine
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	Not Provided
Completion Date	November 2009
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00390676
Other Study ID Numbers ^ICMJE	AHX-01-006
Has Data Monitoring Committee	Not Provided
Responsible Party	Clinical Study Manager, Adherex Technologies
Study Sponsor ^ICMJE	Adherex Technologies, Inc.
Collaborators ^ICMJE	US Oncology Research
Investigators ^ICMJE	Not Provided
Information Provided By	Adherex Technologies, Inc.
Verification Date	December 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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