Study To Evaluate The Clinical Benefit Response In Cancer Patients With Advanced Disease With AMT2003 Versus Placebo

Study Overview

Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo

The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced disease. The primary evaluation criterion is clinical benefit response.

The study will include patients with a variety of solid tumors (i.e. esophageal, colon, pancreatic, bronchial, gastric, hepatocellular, gall bladder, prostate and gynaecological carcinomas.) The clinical benefit response - CBR, is an end point that provides a clinical measure for symptom improvement in patients. The key evaluation parameters for CBR will be assessment of pain, the ability to perform daily activities and weight change.

Gastrointestinal Cancer
Prostate Cancer
Genital Neoplasms, Female

DRUG: AMT2003

AMT/P2CA/001
LC003AURON2005

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-05-31	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-03-19
First Submitted that Met QC Criteria 2006-05-31	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-03-20
First Posted (ESTIMATED) 2006-06-01	Results First Posted N/A	Last Verified 2013-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: AMT2003	DRUG: AMT2003

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: AMT2003

DRUG: AMT2003

Primary Outcome Measures	Measure Description	Time Frame
Improvement in clinical benefit response		Jan 2010

Secondary Outcome Measures	Measure Description	Time Frame
Progression free survival		Jan 2010
Overall survival		Jan 2010
Overall response rate		2010
Duration of response		January 2010
Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30])		Jan 2010
Safety and tolerability		Jan 2010

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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 at least 3 months

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 birth control methods
Concurrent severe or uncontrolled medical disease
Acute or chronic liver disease
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 this study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Joachim Drevs, PD Dr. Med, Clinic SanaFontis

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record