Back to resultsStudy to Evaluate Progression Free Survival in Cancer Patients With Advanced Colorectal Carcinoma With AMT2003
Primary Purpose
Colorectal Carcinoma
Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
AMT2003
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Carcinoma focused on measuring Advanced Colorectal Carcinoma
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 of 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 method of birth control
- 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 in the study
Sites / Locations
- Clinic SanaFontis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AMT2003
Arm Description
Outcomes
Primary Outcome Measures
Progression free survival;at 18 weeks after registration
Secondary Outcome Measures
Best overall response rate (ORR, CR and PR) within 18 weeks after registration
Progression Free survival time (PFS), over complete observation period
Overall Survival (OS) time
Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)
Safety and Tolerability
Full Information
NCT ID
NCT00405561
First Posted
November 29, 2006
Last Updated
March 19, 2013
Sponsor
Auron Healthcare GmbH
1. Study Identification
Unique Protocol Identification Number
NCT00405561
Brief Title
Study to Evaluate Progression Free Survival in Cancer Patients With Advanced Colorectal Carcinoma With AMT2003
Official Title
A Prospective, Open, Single-Arm, Multicenter Phase II Clinical Trial to Evaluate the Progression Free Survival and Safety in Patients With Advanced Colorectal Carcinoma Treated With AMT2003
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy
Study Start Date
October 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 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 efficacy and safety of AMT2003 in cancer patients with advanced colorectal carcinoma.
The primary endpoint is progression free survival rate at 18 weeks after registration
Detailed Description
The study will include patients with advanced colorectal carcinoma that is refractory to standard therapy or for which no effective standard therapy exists. Eligible patients must have had at least second-line chemotherapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Carcinoma
Keywords
Advanced Colorectal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
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
Progression free survival;at 18 weeks after registration
Time Frame
2010
Secondary Outcome Measure Information:
Title
Best overall response rate (ORR, CR and PR) within 18 weeks after registration
Time Frame
2010
Title
Progression Free survival time (PFS), over complete observation period
Time Frame
2010
Title
Overall Survival (OS) time
Time Frame
2010
Title
Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)
Time Frame
2010
Title
Safety and Tolerability
Time Frame
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 of 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 method of birth control
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 in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Drevs, PD Dr. med.
Organizational Affiliation
Clinic Sanafontis, Freiburg
Official's Role
Principal Investigator
Facility Information:
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
now legally responsible for this study
Learn more about this trial
Study to Evaluate Progression Free Survival in Cancer Patients With Advanced Colorectal Carcinoma With AMT2003
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