NCT00332280

Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Auron Healthcare GmbH · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced disease. The primary evaluation criterion is clinical benefit response.

Detailed description

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.

Conditions

• Gastrointestinal Cancer
• Prostate Cancer
• Genital Neoplasms, Female

Interventions

Type	Name	Description
DRUG	AMT2003

Timeline

• Start date: 2006-05-01
• Primary completion: 2010-01-01
• Completion: 2010-03-01
• First posted: 2006-06-01
• Last updated: 2013-03-20

Locations

2 sites across 2 countries: Bosnia and Herzegovina, Germany