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

Dose Finding, Safety, Pharmacokinetic and Pharmacodynamic Study of the Vascular Targeting Agent Exherin™ (ADH-1) Administered Once Daily for 5 Consecutive Days by Intravenous Infusion in Subjects With N-Cadherin Expressing, Incurable, Solid Tumors (Adherex Protocol Number AHX 01 003)

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00225550
Enrollment
Unknown
Registered
2005-09-26
Start date
Unknown
Completion date
Unknown
Last updated
2007-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Keywords

Cancer;, Tumors;, Neoplasms;, Anticarcinogenic Agents;, Antineoplastic Agents;, Cadherins

Brief 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 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.

Interventions

DRUGADH -1 (Exherin™)

Sponsors

Adherex Technologies, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026