TerminatedNCT00405873Updated Mar 20, 2013

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

A Phase 2 interventional study of AMT2003 in Hepatocellular Carcinoma, sponsored by Auron Healthcare GmbH. Terminated at 2 sites in Germany. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2013-03-20.

Sponsored by Auron Healthcare GmbH · Phase 2, Interventional, and Treatment

Why this study was terminated

Lack of efficacy

Phase: Phase 2
Study type: Interventional
Enrollment: 73
Allocation: Non-randomized
Ages: 18 Years to 79 Years
Sex: All

Study 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

Read the 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.

Conditions studied

Hepatocellular Carcinoma

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Keywords

Primary hepatocellular carcinoma
Liver cancer
Tumour response
Quality of life

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 73 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Auron Healthcare GmbH is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 79 Years
Sexes eligible: 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

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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 73 participants (actual)

Study arms

Experimental
AMT2003
Drug: AMT2003

Interventions

DrugAMT2003

What researchers measure

Primary outcomes

Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later
Time frame: March 2010

Secondary outcomes

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

Study locations

2 sites

University Hospital Freiburg, Dept. of Internal Medicine II
Freiburg im Breisgau, Baaden-Wuerttemberg 79106, Germany
Clinic SanaFontis
Freiburg im Breisgau, 79111, Germany

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00405873
Lead sponsor: Auron Healthcare GmbH
Responsible party: Sponsor
First posted: Nov 30, 2006
Start date: Mar 2007
Primary completion: Mar 2010
Completion: Mar 2010
Last update: Mar 20, 2013

Study contacts

Hubert Blum, Prof. Dr. med. Dr. h. c.

principal investigator · University Hospital Freiburg

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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