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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

PhaseTypeStatusAgeSponsorProtocol IDs
Phase III, Phase IITreatmentActive18 to 79Pharmaceutical / IndustryAMT/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
  • 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Auron Healthcare GmbH

Joachim Drevs, PD Dr. MedPrincipal Investigator

Joachim Drevs, PD Dr. MedPh: +49-761-888-595959
  Email: drevs@sanafontis.com

Trial Sites

Bosnia and Herzegovina
  Sarajevo
 Klinicki Centar Univerziteta Sarajevo - Klinika za gastroenterohepatologiju
 Mehmed Gribajcevic, Prof. Ph: +387 71 233-456
  Email: gastro@bih.net.ba 5
 Jasmina Krehic, Mr.sci. Dr. Ph: +387 33 266-861
  Email: jaja@bih.net.ba 6
 Mehmed Gribajcevic, Prof.Principal Investigator
Germany
  Freiburg im Breisgau
 Klinik Sana Fontis
 Joachim Drevs, PD Dr. Med Ph: +49-761-888-595959
  Email: drevs@sanafontis.com 7
 Joachim Drevs, PD Dr. MedPrincipal Investigator

Link to the current ClinicalTrials.gov record. 8
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.



Table of Links

1http://www.cancer.gov/clinicaltrials/learning
2http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials
3http://www.cancer.gov/clinicaltrials/learning/questions-to-ask-about-participat
ing
4http://www.nlm.nih.gov/medlineplus/druginformation.html
5 mailto:gastro@bih.net.ba?Subject=NCT00332280,AMT/P2CA/001
:- Study to Evaluate the Clinical Benefit Response in Cancer Patients With
Advanced Disease With AMT2003 Versus Placebo
6 mailto:jaja@bih.net.ba?Subject=NCT00332280,AMT/P2CA/001:-
Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced
Disease With AMT2003 Versus Placebo
7 mailto:drevs@sanafontis.com?Subject=NCT00332280,AMT/P2CA/
001:- Study to Evaluate the Clinical Benefit Response in Cancer Patients With
Advanced Disease With AMT2003 Versus Placebo
8http://clinicaltrials.gov/show/NCT00332280