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

NCT ID: NCT00405873

Last Updated: 2013-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-03-31

Brief Summary

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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

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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

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AMT2003

Group Type EXPERIMENTAL

AMT2003

Intervention Type DRUG

Interventions

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AMT2003

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Auron Healthcare GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

University Hospital Freiburg

Locations

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University Hospital Freiburg, Dept. of Internal Medicine II

Freiburg im Breisgau, Baaden-Wuerttemberg, Germany

Site Status

Clinic SanaFontis

Freiburg im Breisgau, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.alpiniainstitute.com

Now legally responsible for study

Other Identifiers

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LC004AURON2005

Identifier Type: -

Identifier Source: secondary_id

AMT/P2GI/001 Part I

Identifier Type: -

Identifier Source: org_study_id

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