Gastrointestinal Cancer, Genital Neoplasms, Female, Prostate Cancer
Conditions
Keywords
solid tumors, clinical benefit, quality of life, esophageal cancer, colon cancer, pancreatic cancer, gastric cancer, liver cancer, gall bladder cancer, prostate cancer, gynecological cancer, lung cancer, Tumors of GI tract, prostate and gynaecological
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 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.
Interventions
DRUGAMT2003
Sponsors
Auron Healthcare GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in clinical benefit response | Jan 2010 |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | Jan 2010 |
| Overall response rate | 2010 |
| Progression free survival | Jan 2010 |
| Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]) | Jan 2010 |
| Safety and tolerability | Jan 2010 |
| Duration of response | January 2010 |
Countries
Bosnia and Herzegovina, Germany
Outcome results
None listed