A Prospective, Randomised, Multicenter Phase II/III Clinical Trial to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT Versus Placebo
The study will include patients with a variety of solid tumors (i.e. esophageal, colon,
pancreatic, bronchial, gastric, hepatocellular, gall bladder, prostate and gynaecological
carcinomas.)
The clinical benefit response - CBR, is an end point that provides a clinical measure for
symptom improvement in patients. The key evaluation parameters for CBR will be assessment of
pain, the ability to perform daily activities and weight change.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Improvement in clinical benefit response
Jan 2010
No
Joachim Drevs, PD Dr. Med
Principal Investigator
Clinic SanaFontis
Germany: Federal Institute for Drugs and Medical Devices
AMT/P2CA/001
NCT00332280
May 2006
March 2010
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