NCT00225550

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
Last Updated

August 6, 2007

Status Verified

August 1, 2007

First QC Date

September 22, 2005

Last Update Submit

August 3, 2007

Conditions

Neoplasms

Keywords

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

Interventions

ADH -1 (Exherin™)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

N-Ac-CHAVC-NH2

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 22, 2005

First Posted

September 26, 2005

Last Updated

August 6, 2007

Record last verified: 2007-08

Locations

US(1)