Clinical trial NCT00264433: A Study of the Safety and Effects of ADH-1 Given Intravenously as a Single Agent
Official title: An Open-Label Phase 2a Study in Subjects With N-Cadherin Positive, Advanced or Recurrent Solid Tumors to Investigate the Safety and Efficacy of ADH-1 Administered Intravenously as a Single Agent (Adherex Protocol Number AHX-01-201)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms
Keywords: Cancer; Tumors; Neoplasms; Anticarcinogenic Agents; Antineoplastic Agents
Cadherins; Non-Small-Cell Lung Carcinoma; Esophageal Cancer; Gastric Cancer; Renal Cell Carcinoma; Hepatocellular Carcinoma; Adrenocortical Carcinoma
Lead sponsor: Adherex Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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
* 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)

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Florida Cancer Specialist
state: Florida
city: Chapel Hill
country: United States
facility: Lineberger Comprensive Cancer Center
state: North Carolina
city: Durham
country: United States
facility: Duke Comprehensive Cancer Centre
state: North Carolina
city: Chattanooga
country: United States
facility: Chattanooga Oncology and Hematology Associates
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer Agency - Vancouver Centre
state: British Columbia
city: Halifax
country: Canada
facility: Centre for Clinical Research
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital Regional Cancer Center (TOHRCC)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: McGill University Jewish General Hospital
state: Quebec
Study officials:
References: