NCT Number: NCT00265057
Study of ADH-1 Given Intravenously to Patients With Solid Tumors
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 ADH-1 in subjects with incurable, solid tumors with a protein biomarker called N-cadherin. This study will identify the amount of ADH-1 that subjects can tolerate.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Instituto Europeo di Oncologia, Milan, Italy
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) refractory to standard curative therapy or for which no curative therapy exists. Study currently enrolling only patients with non-small cell lung cancer or advanced ovarian cancer to the safety expansion phase.
- Clinically or radiologically documented measurable disease.
- Immunohistochemical evidence of N-cadherin expression (at least 1+ positive) in archived or fresh tumor tissue
- Adequate performance status and organ function, as evidenced by hematological and biochemical blood testing and electrocardiogram (ECG)
Exclusion criteria
- Receipt of ADH-1 prior to this clinical study
- Chemotherapy, radiotherapy, or any other investigational drug within 30 days before study entry
- History of primary brain tumors 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 spinal cord compression. History of tumors that have shown clinically significant evidence of active bleeding (e.g., gross hemoptysis, hematemesis, hematuria, melena, or bleeding superficial tumor) within 12 weeks before study entry.
- Stroke, major surgery, or other major tissue injury within 30 days before study entry
- History of congestive heart failure, myocardial infarction, angina, life threatening arrhythmias, significant electrocardiogram (ECG) abnormalities, or known hypercoagulable states
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Adherex Technologies, Inc.
Industry
Registry information
Official study title
Dose Finding, Safety, Pharmacokinetic and Pharmacodynamic Study of the Vascular Targeting Agent Exherin™ (ADH-1) Administered Once Weekly in 3 Week Cycles by Intravenous Infusion in Patients With N-Cadherin Expressing, Incurable, Solid Tumors (Adherex Protocol Number AHX-01-004)
Important dates
- Study start
- 2005
- Study completion
- 2008
- First posted
- Dec 14, 2005
- 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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