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

Primary Purpose

Hepatocellular Carcinoma

Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
AMT2003
Sponsored by
Auron Healthcare GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Primary hepatocellular carcinoma, Liver cancer, Tumour response, Quality of life

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Freiburg, Dept. of Internal Medicine II
  • Clinic SanaFontis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AMT2003

Arm Description

Outcomes

Primary Outcome Measures

Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later

Secondary Outcome Measures

Progression Free Survival (PFS) time
Overall Survival (OS) time
Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)
Safety and Tolerability

Full Information

First Posted
November 29, 2006
Last Updated
March 19, 2013
Sponsor
Auron Healthcare GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00405873
Brief Title
Study to Evaluate Tumour Response in Cancer Patients With Advanced Hepatocellular Carcinoma (Liver Cancer) With AMT2003
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 Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy
Study Start Date
March 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Auron Healthcare GmbH

4. Oversight

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Primary hepatocellular carcinoma, Liver cancer, Tumour response, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMT2003
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AMT2003
Primary Outcome Measure Information:
Title
Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later
Time Frame
March 2010
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS) time
Time Frame
March 2010
Title
Overall Survival (OS) time
Time Frame
March 2010
Title
Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)
Time Frame
March 2010
Title
Safety and Tolerability
Time Frame
March 2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubert Blum, Prof. Dr. med. Dr. h. c.
Organizational Affiliation
University Hospital Freiburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Freiburg, Dept. of Internal Medicine II
City
Freiburg im Breisgau
State/Province
Baaden-Wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Clinic SanaFontis
City
Freiburg im Breisgau
ZIP/Postal Code
79111
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.alpiniainstitute.com
Description
Now legally responsible for study

Learn more about this trial

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

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