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

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. Identifier: NCT00405873
Recruitment Status : Terminated (Lack of efficacy)
First Posted : November 30, 2006
Last Update Posted : March 20, 2013
Information provided by (Responsible Party):
Auron Healthcare GmbH

Brief Summary:

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 or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: AMT2003 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
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
Study Start Date : March 2007
Primary Completion Date : March 2010
Study Completion Date : March 2010

Arm Intervention/treatment
Experimental: AMT2003 Drug: AMT2003

Primary Outcome Measures :
  1. Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later [ Time Frame: March 2010 ]

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

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 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

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 identifier (NCT number): NCT00405873

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
Principal Investigator: Hubert Blum, Prof. Dr. med. Dr. h. c. University Hospital Freiburg

Additional Information:
Responsible Party: Auron Healthcare GmbH Identifier: NCT00405873     History of Changes
Other Study ID Numbers: AMT/P2GI/001 Part I
First Posted: November 30, 2006    Key Record Dates
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, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases