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A Study of the Safety and Effects of ADH-1 Given Daily to Subjects With Solid Tumors

A

Adherex Technologies

Status and phase

Terminated
Phase 2
Phase 1

Conditions

Neoplasms

Treatments

Drug: ADH -1 (Exherin™)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00225550
Adherex Protocol AHX-01-003

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
  • 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
  • History of spinal cord compression or tumors that have shown any evidence of active bleeding within 30 days 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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