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

Adherex Technologies

Status and phase

Completed

Phase 1

Conditions

Neoplasms

Treatments

Drug: ADH -1 and carboplatin

Drug: ADH -1 and capecitabine

Drug: ADH -1 and docetaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00390676

AHX-01-006

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 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.

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) 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