Study Stopped
Lack of efficacy
Study to Evaluate Tumour Response in Cancer Patients With Advanced Hepatocellular Carcinoma (Liver Cancer) With AMT2003
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
2 other identifiers
interventional
73
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hepatocellular-carcinoma
Started Mar 2007
Typical duration for phase_2 hepatocellular-carcinoma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2006
CompletedFirst Posted
Study publicly available on registry
November 30, 2006
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedMarch 20, 2013
March 1, 2013
3 years
November 29, 2006
March 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later
March 2010
Secondary Outcomes (4)
Progression Free Survival (PFS) time
March 2010
Overall Survival (OS) time
March 2010
Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)
March 2010
Safety and Tolerability
March 2010
Study Arms (1)
AMT2003
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospital Freiburg, Dept. of Internal Medicine II
Freiburg im Breisgau, Baaden-Wuerttemberg, 79106, Germany
Clinic SanaFontis
Freiburg im Breisgau, 79111, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hubert Blum, Prof. Dr. med. Dr. h. c.
University Hospital Freiburg
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2006
First Posted
November 30, 2006
Study Start
March 1, 2007
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
March 20, 2013
Record last verified: 2013-03