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OpenTrials
Completed

NCT Number: NCT00390676

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

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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rocky Mountain Cancer Centers, Denver, Colorado, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADH -1 and carboplatin

Drug

ADH -1 and docetaxel

Drug

ADH -1 and capecitabine

Drug

Sponsors and collaborators

Lead sponsor

Adherex Technologies, Inc.

Industry

Collaborators

  • US Oncology Research

Registry information

Official study 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)

Important dates

Study start
2006
Study completion
2009
First posted
Oct 20, 2006
Registry last updated
Dec 28, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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