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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

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)


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

Adherex Protocol # AHX-01-201

NCT ID:

NCT00264433

Start Date:

Completion Date:

Related Keywords:

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

Name

Location

Florida Cancer Specialist Fort Myers, Florida  33901
Chattanooga Oncology and Hematology Associates Chattanooga, Tennessee  37404
Sarah Cannon Research Institute Nashville, Tennessee  37203
Lineberger Comprensive Cancer Center Chapel Hill, North Carolina  27599
Duke Comprehensive Cancer Centre Durham, North Carolina  27703