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Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo

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ClinicalTrials.gov Identifier: NCT00332280
Recruitment Status : Terminated (Lack of efficacy. Stopped at first interim evaluation point)
First Posted : June 1, 2006
Last Update Posted : March 20, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Prostate Cancer Genital Neoplasms, Female Drug: AMT2003 Phase 2 Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2006
Primary Completion Date : January 2010
Study Completion Date : March 2010

Arms and Interventions

Arm Intervention/treatment
Experimental: AMT2003 Drug: AMT2003

Outcome Measures

Primary Outcome Measures :
  1. Improvement in clinical benefit response [ Time Frame: Jan 2010 ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: Jan 2010 ]
  2. Overall survival [ Time Frame: Jan 2010 ]
  3. Overall response rate [ Time Frame: 2010 ]
  4. Duration of response [ Time Frame: January 2010 ]
  5. Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]) [ Time Frame: Jan 2010 ]
  6. Safety and tolerability [ Time Frame: Jan 2010 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332280

Bosnia and Herzegovina
Klinicki Centar Univerziteta Sarajevo - Klinika za gastroenterohepatologiju
Sarajevo, Bosnia and Herzegovina
Clinic SanaFontis
Freiburg im Breisgau, Germany, 79111
Sponsors and Collaborators
Auron Healthcare GmbH
Principal Investigator: Joachim Drevs, PD Dr. Med Clinic SanaFontis
More Information

Additional Information:
Responsible Party: Auron Healthcare GmbH
ClinicalTrials.gov Identifier: NCT00332280     History of Changes
Other Study ID Numbers: AMT/P2CA/001
First Posted: June 1, 2006    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013

Keywords provided by Auron Healthcare GmbH:
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

Additional relevant MeSH terms:
Prostatic Neoplasms
Gastrointestinal Neoplasms
Genital Neoplasms, Female
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases