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

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00405873
• Other study ID #: AMT/P2GI/001 Part I
• Secondary ID: LC004AURON2005
• Status: Terminated
• Phase: Phase 2
• First received: November 29, 2006
• Last updated: March 19, 2013
• Start date: March 2007
• Est. completion date: March 2010

Study information

• Verified date: March 2013
• Source: Auron Healthcare GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 73
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• AMT2003

Locations

Country	Name	City	State
Germany	Clinic SanaFontis	Freiburg im Breisgau
Germany	University Hospital Freiburg, Dept. of Internal Medicine II	Freiburg im Breisgau	Baaden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
Auron Healthcare GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later		March 2010	No
Secondary	Progression Free Survival (PFS) time		March 2010	No
Secondary	Overall Survival (OS) time		March 2010	No
Secondary	Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)		March 2010	No
Secondary	Safety and Tolerability		March 2010	Yes

External Links

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