Status:
TERMINATED
Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo
Lead Sponsor:
Auron Healthcare GmbH
Conditions:
Gastrointestinal Cancer
Prostate Cancer
Eligibility:
All Genders
18-79 years
Phase:
PHASE2
PHASE3
Brief 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 clin...
Eligibility Criteria
Inclusion
- Cancer confirmed by histology or cytology
- At least one measurable lesion
- Advanced disease refractory to standard therapy or for which no standard therapy exists
- Life expectancy at least 3 months
Exclusion
- Known secondary neoplasia or central nervous system (CNS) metastases, acute or chronic leukemia, lymphoma or multiple myeloma
- Body weight below 45 kg
- Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective birth control methods
- Concurrent severe or uncontrolled medical disease
- Acute or chronic liver disease
- Confirmed diagnosis of HIV
- Insulin dependent diabetes mellitus/abnormal glucose tolerance test (GTT)/latent diabetes mellitus type I or II
- Chemotherapy or radiotherapy less than 4 weeks prior to entry
- Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery)
- Participation in a clinical trial less than 30 days prior to entry into this study
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00332280
Start Date
May 1 2006
End Date
March 1 2010
Last Update
March 20 2013
Active Locations (2)
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1
Klinicki Centar Univerziteta Sarajevo - Klinika za gastroenterohepatologiju
Sarajevo, Bosnia and Herzegovina
2
Clinic SanaFontis
Freiburg im Breisgau, Germany, 79111