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

Neoplasms Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00390676
• Other study ID #: AHX-01-006
• Status: Completed
• Phase: Phase 1
• First received: October 18, 2006
• Last updated: December 27, 2010
• Start date: November 2006
• Est. completion date: November 2009

Study information

• Verified date: December 2010
• Source: Adherex Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• ADH -1 and carboplatin

• ADH -1 and docetaxel

• ADH -1 and capecitabine

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Adherex Technologies, Inc.	US Oncology Research

Country where clinical trial is conducted

United States, 

External Links

•   Adherex Technologies Inc. Corporate Homepage