Back to resultsStudy to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo
Primary Purpose
Gastrointestinal Cancer, Prostate Cancer, Genital Neoplasms, Female
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AMT2003
Sponsored by
About this trial
This is an interventional treatment trial for Gastrointestinal Cancer focused on measuring solid tumors, clinical benefit, quality of life, esophageal cancer, colon cancer, pancreatic cancer, gastric cancer, liver cancer, gall bladder cancer, prostate cancer, gynecological cancer, lung cancer, Tumors of GI tract, prostate and gynaecological
Eligibility Criteria
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
Sites / Locations
- Klinicki Centar Univerziteta Sarajevo - Klinika za gastroenterohepatologiju
- Clinic SanaFontis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AMT2003
Arm Description
Outcomes
Primary Outcome Measures
Improvement in clinical benefit response
Secondary Outcome Measures
Progression free survival
Overall survival
Overall response rate
Duration of response
Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30])
Safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00332280
Brief Title
Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo
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 Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy. Stopped at first interim evaluation point
Study Start Date
May 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Auron Healthcare GmbH
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer, Prostate Cancer, Genital Neoplasms, Female
Keywords
solid tumors, clinical benefit, quality of life, esophageal cancer, colon cancer, pancreatic cancer, gastric cancer, liver cancer, gall bladder cancer, prostate cancer, gynecological cancer, lung cancer, Tumors of GI tract, prostate and gynaecological
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMT2003
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AMT2003
Primary Outcome Measure Information:
Title
Improvement in clinical benefit response
Time Frame
Jan 2010
Secondary Outcome Measure Information:
Title
Progression free survival
Time Frame
Jan 2010
Title
Overall survival
Time Frame
Jan 2010
Title
Overall response rate
Time Frame
2010
Title
Duration of response
Time Frame
January 2010
Title
Quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30])
Time Frame
Jan 2010
Title
Safety and tolerability
Time Frame
Jan 2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Drevs, PD Dr. Med
Organizational Affiliation
Clinic SanaFontis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinicki Centar Univerziteta Sarajevo - Klinika za gastroenterohepatologiju
City
Sarajevo
Country
Bosnia and Herzegovina
Facility Name
Clinic SanaFontis
City
Freiburg im Breisgau
ZIP/Postal Code
79111
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.alpiniainstitute.com
Description
Alpinia Institute now legally responsible for the study
Learn more about this trial
Study to Evaluate the Clinical Benefit Response in Cancer Patients With Advanced Disease With AMT2003 Versus Placebo
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