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

This study has been terminated.
(Lack of efficacy. Stopped at first interim evaluation point)
Sponsor:
Information provided by (Responsible Party):
Auron Healthcare GmbH
ClinicalTrials.gov Identifier:
NCT00332280
First received: May 31, 2006
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Gastrointestinal Cancer
Prostate Cancer
Genital Neoplasms, Female
Drug: AMT2003
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Auron Healthcare GmbH:

Primary Outcome Measures:
  • Improvement in clinical benefit response [ Time Frame: Jan 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival [ Time Frame: Jan 2010 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Jan 2010 ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: January 2010 ] [ Designated as safety issue: No ]
  • Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]) [ Time Frame: Jan 2010 ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: Jan 2010 ] [ Designated as safety issue: Yes ]

Enrollment: 67
Study Start Date: May 2006
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMT2003 Drug: AMT2003

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332280

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

Additional Information:
No publications provided

Responsible Party: Auron Healthcare GmbH
ClinicalTrials.gov Identifier: NCT00332280     History of Changes
Other Study ID Numbers: AMT/P2CA/001, LC003AURON2005
Study First Received: May 31, 2006
Last Updated: March 19, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on September 16, 2014