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Dose Finding, Safety, Pharmacokinetic and Pharmacodynamic Study of the Vascular Targeting Agent Exherin™ (ADH-1) Administered Once Daily for 5 Consecutive Days by Intravenous Infusion in Subjects With N-Cadherin Expressing, Incurable, Solid Tumors (Adherex Protocol Number AHX 01 003)


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasms

Thank you

Trial Information

Dose Finding, Safety, Pharmacokinetic and Pharmacodynamic Study of the Vascular Targeting Agent Exherin™ (ADH-1) Administered Once Daily for 5 Consecutive Days by Intravenous Infusion in Subjects With N-Cadherin Expressing, Incurable, Solid Tumors (Adherex Protocol Number AHX 01 003)

Inclusion 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

- 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)

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 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

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-01-003

NCT ID:

NCT00225550

Start Date:

Completion Date:

Related Keywords:

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

Name

Location

University of Texas M.D. Anderson Cancer CenterHouston, Texas  77030