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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00332280
• Other study ID #: AMT/P2CA/001
• Secondary ID: LC003AURON2005
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: May 31, 2006
• Last updated: March 19, 2013
• Start date: May 2006
• 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 disease.

The primary evaluation criterion is clinical benefit response.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: March 2010
• Est. primary completion date: January 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 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

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Genital Neoplasms, Female
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• AMT2003

Locations

Country	Name	City	State
Bosnia and Herzegovina	Klinicki Centar Univerziteta Sarajevo - Klinika za gastroenterohepatologiju	Sarajevo
Germany	Clinic SanaFontis	Freiburg im Breisgau

Sponsors (1)

Lead Sponsor	Collaborator
Auron Healthcare GmbH

Countries where clinical trial is conducted

Bosnia and Herzegovina,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in clinical benefit response		Jan 2010	No
Secondary	Progression free survival		Jan 2010	No
Secondary	Overall survival		Jan 2010	No
Secondary	Overall response rate		2010	No
Secondary	Duration of response		January 2010	No
Secondary	Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30])		Jan 2010	No
Secondary	Safety and tolerability		Jan 2010	Yes

External Links

•   Alpinia Institute now legally responsible for the study