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Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo
Basic Trial Information Trial Description Summary Further Trial Information Eligibility Criteria Trial Contact Information
Basic Trial Information
Phase | Type | Status | Age | Protocol IDs |
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Phase III, Phase II | Treatment | Active | 18 to 79 | AMT/P2CA/001 LC003AURON2005, NCT00332280 |
Trial Description
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. Further Study Information 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. 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
- 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
Trial Contact Information
Trial Lead Organizations/Sponsors Auron Healthcare GmbH Joachim Drevs, PD Dr. Med | ![](https://webarchive.library.unt.edu/eot2008/20090509114031im_/http://www.cancer.gov/images/spacer.gif) | Principal Investigator |
Trial Sites
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Bosnia and Herzegovina |
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Sarajevo |
![](https://webarchive.library.unt.edu/eot2008/20090509114031im_/http://www.cancer.gov/images/spacer.gif) |
| | | | | | | Klinicki Centar Univerziteta Sarajevo - Klinika za gastroenterohepatologiju |
| | Mehmed Gribajcevic, Prof. |
Ph: +387 71 233-456 |
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Email:
gastro@bih.net.ba |
| | Jasmina Krehic, Mr.sci. Dr. |
Ph: +387 33 266-861 |
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Email:
jaja@bih.net.ba |
| | Mehmed Gribajcevic, Prof. | Principal Investigator |
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Germany |
![](https://webarchive.library.unt.edu/eot2008/20090509114031im_/http://www.cancer.gov/images/spacer.gif) |
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Freiburg im Breisgau |
![](https://webarchive.library.unt.edu/eot2008/20090509114031im_/http://www.cancer.gov/images/spacer.gif) |
| | | Klinik Sana Fontis |
| | Joachim Drevs, PD Dr. Med |
Ph: +49-761-888-595959 |
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Email:
drevs@sanafontis.com |
| | Joachim Drevs, PD Dr. Med | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00332280 Information obtained from ClinicalTrials.gov on March 18, 2009 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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