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Clinical Trial Name -Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo
| Original Study ID : AMT/P2CA/001 |
| Secondary ID : LC003AURON2005 |
| NCT ID : NCT00332280 |
| Brief Title : Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo |
| Official Title : 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 |
| 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. |
| Source : Auron Healthcare GmbH |
| 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. |
| Overall Status : Recruiting |
| Start Date : May 2006 |
| End Date : December 2008 |
| Completion Date : December 2008 |
| Official Title : Phase 2/Phase 3 |
| Phase : Interventional |
| Study Design : Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Enrollment : 200 |
| Verification Date : November 2006 |
| First Received Date : May 31, 2006 |
| Trial Eligibility |
| Criteria : 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 |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : 79 Years |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Klinicki Centar Univerziteta Sarajevo - Klinika za gastroenterohepatologiju |
| Status : Recruiting |
| City : Sarajevo |
| Country : Bosnia and Herzegovina |
| Facility Name : Clinic SanaFontis |
| Status : Recruiting |
| City : Freiburg im Breisgau |
| Zip Code : 79111 |
| Country : Germany |
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