MedDataX Logo

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

NCT ID: NCT00390676

Last Updated: 2010-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neoplasms

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

cancer tumors anticarcinogenic agents antineoplastic agents cadherins solid tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ADH -1 and carboplatin

Intervention Type DRUG

ADH -1 and docetaxel

Intervention Type DRUG

ADH -1 and capecitabine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

US Oncology Research

INDUSTRY

Sponsor Role collaborator

Adherex Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adherex Technologies

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Site Status

Cancer Centers of Florida

Ocoee, Florida, United States

Site Status

Central Indiana Cancer Centers

Indianapolis, Indiana, United States

Site Status

New York Oncology Hematology P.C.

Albany, New York, United States

Site Status

Dayton Oncology & Hematology, P.A

Kettering, Ohio, United States

Site Status

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Site Status

Texas Oncology, PA

Dallas, Texas, United States

Site Status

Tyler Cancer Center

Tyler, Texas, United States

Site Status

Virginia Oncology Associates

Norfolk, Virginia, United States

Site Status

Northwest Cancer Specialists - Vancouver Cancer Center

Vancouver, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.adherex.com

Adherex Technologies Inc. Corporate Homepage

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AHX-01-006

Identifier Type: -

Identifier Source: org_study_id