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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00405873

Enrollment

Registered

2006-11-30

Start date

2007-03-31

Completion date

2010-03-31

Last updated

2013-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Primary hepatocellular carcinoma, Liver cancer, Tumour response, Quality of life

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.

Interventions

DRUGAMT2003

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026