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Study to Evaluate Progression Free Survival in Cancer Patients With Advanced Colorectal Carcinoma With AMT2003
This study is currently recruiting participants.
Verified by Auron Healthcare GmbH, November 2006
Sponsored by: Auron Healthcare GmbH
Information provided by: Auron Healthcare GmbH
ClinicalTrials.gov Identifier: NCT00405561
  Purpose

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


Condition Intervention Phase
Colorectal Carcinoma
Drug: AMT2003
Phase II
Phase III

MedlinePlus related topics: Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Auron Healthcare GmbH:

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

Estimated Enrollment: 67
Study Start Date: October 2006
Estimated Study Completion Date: June 2009
Detailed Description:

The study will include patients with advanced colorectal carcinoma that is refractory to standard therapy or for which no effective stabdard therapy exists. Eligible patients must have had at least second-line chemotherapy.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 atleast 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00405561

Contacts
Contact: Joachim Drevs, PD Dr. med. +49-761-888-595959 drevs@sanafontis.com

Locations
Germany
Clinic SanaFontis Recruiting
Freiburg im Breisgau, Germany, 79111
Contact: Joachim Drevs, PD Dr. Med     +49-761-888-595959     drevs@sanafontis.com    
Principal Investigator: Joachim Drevs, PD Dr. Med            
Sponsors and Collaborators
Auron Healthcare GmbH
Investigators
Principal Investigator: Joachim Drevs, PD Dr. med. Clinic Sanafontis, Freiburg
  More Information

Clinical Trial Site  This link exits the ClinicalTrials.gov site

Study ID Numbers: AMT/P2GI/001 Part III, LC001Auron2005
Study First Received: November 29, 2006
Last Updated: November 29, 2006
ClinicalTrials.gov Identifier: NCT00405561  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Auron Healthcare GmbH:
Advanced Colorectal Carcinoma

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Disease Progression
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009