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

Phase 2

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: AMT2003

• Registration Number: NCT00405873
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2006-11-29
• Study First Submitted QC: 2006-11-29
• Study First Posted: 2006-11-30
• Study Start: 2007-03
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-19
• Last Update Posted: 2013-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMT2003	AMT2003	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

University Hospital Freiburg, Dept. of Internal Medicine II; 🇩🇪 Freiburg im Breisgau, Baaden-Wuerttemberg, Germany

Clinic SanaFontis; 🇩🇪 Freiburg im Breisgau, Germany