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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:
ClinicalTrials.gov Identifier:
NCT00405873
First Posted: November 30, 2006
Last Update Posted: March 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Auron Healthcare GmbH
  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
Intervention Model: Single Group Assignment
Masking: None (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

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 ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS) time [ Time Frame: March 2010 ]
  • Overall Survival (OS) time [ Time Frame: March 2010 ]
  • Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index) [ Time Frame: March 2010 ]
  • Safety and Tolerability [ Time Frame: March 2010 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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:
Responsible Party: Auron Healthcare GmbH
ClinicalTrials.gov Identifier: NCT00405873     History of Changes
Other Study ID Numbers: AMT/P2GI/001 Part I
LC004AURON2005
First Submitted: November 29, 2006
First Posted: November 30, 2006
Last Update Posted: March 20, 2013
Last Verified: March 2013

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

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