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Study to Evaluate Tumour Response in Cancer Patients With Advanced Hepatocellular Carcinoma (Liver Cancer) With AMT2003

This study has been terminated.
(Lack of efficacy)
Sponsor:
Information provided by (Responsible Party):
Auron Healthcare GmbH
ClinicalTrials.gov Identifier:
NCT00405873
First received: November 29, 2006
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced primary hepatocellular carcinoma

The primary endpoint is best overall response rate within 20 weeks after registration


Condition Intervention Phase
Hepatocellular Carcinoma
 Drug: AMT2003
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Open, Single-arm, Multicenter Phase II Clinical Trial to Evaluate the Tumour Response and Safety in Patients With Advanced Primary Hepatocellular Carcinoma Treated With AMT2003

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

Further study details as provided by Auron Healthcare GmbH:

Primary Outcome Measures:
  • Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later [ Time Frame: March 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS) time [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
  • Overall Survival (OS) time [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
  • Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index) [ Time Frame: March 2010 ] [ Designated as safety issue: No ]
  • Safety and Tolerability [ Time Frame: March 2010 ] [ Designated as safety issue: Yes ]

Enrollment: 73
Study Start Date: March 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMT2003 Drug: AMT2003

Detailed Description:

The study will include patients with advanced primary hepatocellular carcinoma refractory to standard therapy or for which no effective standard therapy exists.

The best overall response rate is the best response recorded from the start of treatment until disease progression / recurrence.

  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 of 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 method of birth control
  • 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 study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00405873

Locations
Germany
University Hospital Freiburg, Dept. of Internal Medicine II
Freiburg im Breisgau, Baaden-Wuerttemberg, Germany, 79106
Clinic SanaFontis
Freiburg im Breisgau, Germany, 79111
Sponsors and Collaborators
Auron Healthcare GmbH
Investigators
Principal Investigator: Hubert Blum, Prof. Dr. med. Dr. h. c. University Hospital Freiburg
  More Information

Additional Information:
Now legally responsible for study  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Auron Healthcare GmbH
ClinicalTrials.gov Identifier: NCT00405873     History of Changes
Other Study ID Numbers: AMT/P2GI/001 Part I, LC004AURON2005
Study First Received: November 29, 2006
Last Updated: March 19, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Auron Healthcare GmbH:
Primary hepatocellular carcinoma
Liver cancer
Tumour response
Quality of life

Additional relevant MeSH terms:
Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on May 22, 2013