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

Phase 2

Terminated

• Conditions: Gastrointestinal Cancer; Prostate Cancer; Genital Neoplasms, Female
• Interventions: Drug: AMT2003

• Registration Number: NCT00332280
• 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 disease.

The primary evaluation criterion is clinical benefit response.

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 Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-31
• Study First Submitted QC: 2006-05-31
• Study First Posted: 2006-06-01
• Primary Completion: 2010-01
• 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: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMT2003	AMT2003	-

Primary Outcome Measures

Name	Time	Method
Improvement in clinical benefit response	Jan 2010

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Klinicki Centar Univerziteta Sarajevo - Klinika za gastroenterohepatologiju; 🇧🇦 Sarajevo, Bosnia and Herzegovina

Clinic SanaFontis; 🇩🇪 Freiburg im Breisgau, Germany