NCT00264433

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 specific incurable, solid tumors with a protein biomarker called N-cadherin. This study will examine the clinical activity of ADH-1.

Trial Health

85
On Track

Trial Health Score

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

Geographic Reach
2 countries

11 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2005

Completed
Last Updated

August 6, 2007

Status Verified

August 1, 2007

First QC Date

December 12, 2005

Last Update Submit

August 3, 2007

Conditions

Neoplasms

Keywords

Cancer; Tumors; Neoplasms; Anticarcinogenic Agents; Antineoplastic AgentsCadherins; Non-Small-Cell Lung Carcinoma; Esophageal Cancer; Gastric Cancer; Renal Cell Carcinoma; Hepatocellular Carcinoma; Adrenocortical Carcinoma

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
  • Histologically proven advanced and/or metastatic solid tumor of one of the following histologies:
  • non-small cell lung cancer (squamous or non-squamous histology),
  • gastroesophageal carcinoma (squamous or adenocarcinoma histology),
  • renal cell carcinoma,
  • hepatocellular carcinoma,
  • adrenocortical carcinoma
  • 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 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 (e.g., gross hemoptysis, hematemesis, hematuria, melena, or bleeding superficial tumor) within 12 weeks before study entry
  • Stroke, major surgery, or other major tissue injury within 30 days before study entry
  • History of:
  • uncontrolled congestive heart failure,
  • coronary artery disease, or life threatening arrhythmias;
  • myocardial infarction less than 12 months prior to study entry;
  • significant ECG abnormalities; or
  • known hypercoagulable states

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Florida Cancer Specialist

Fort Myers, Florida, 33908, United States

Location

Lineberger Comprensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Duke Comprehensive Cancer Centre

Durham, North Carolina, 27703, United States

Location

Chattanooga Oncology and Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Cross Cancer Institute

Edmonton, Alberta, Canada

Location

BC Cancer Agency - Vancouver Centre

Vancouver, British Columbia, Canada

Location

Centre for Clinical Research

Halifax, Nova Scotia, Canada

Location

The Ottawa Hospital Regional Cancer Center (TOHRCC)

Ottawa, Ontario, K1H 1C4, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Links

MeSH Terms

Conditions

NeoplasmsCarcinoma, Non-Small-Cell LungEsophageal NeoplasmsStomach NeoplasmsCarcinoma, Renal CellCarcinoma, HepatocellularAdrenocortical Carcinoma

Interventions

N-Ac-CHAVC-NH2

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesLiver NeoplasmsLiver DiseasesAdrenal Cortex NeoplasmsAdrenal Gland NeoplasmsEndocrine Gland NeoplasmsAdrenal Cortex DiseasesAdrenal Gland DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 12, 2005

First Posted

December 13, 2005

Last Updated

August 6, 2007

Record last verified: 2007-08

Locations

CA(6)US(5)