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

Sponsor

Auron Healthcare GmbH (Industry)

Overall Status

Terminated

CT.gov ID

NCT00332280

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

33.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Cancer Prostate Cancer Genital Neoplasms, Female	Drug: AMT2003	Phase 2/Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomised, Multicenter Phase II/III Clinical Trial to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT Versus Placebo

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AMT2003	Drug: AMT2003

Arm

Intervention/Treatment

Experimental: AMT2003

Drug: AMT2003

Outcome Measures

Primary Outcome Measures

Improvement in clinical benefit response [Jan 2010]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts 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 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinicki Centar Univerziteta Sarajevo - Klinika za gastroenterohepatologiju	Sarajevo		Bosnia and Herzegovina
2	Clinic SanaFontis	Freiburg im Breisgau		Germany	79111