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Study to Evaluate Progression Free Survival in Cancer Patients With Advanced Colorectal Carcinoma With AMT2003

This study has been terminated.
(Lack of efficacy)
Sponsor:
Information provided by (Responsible Party):
Auron Healthcare GmbH
ClinicalTrials.gov Identifier:
NCT00405561
First received: November 29, 2006
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Auron Healthcare GmbH:

Primary Outcome Measures:
  • Progression free survival;at 18 weeks after registration [ Time Frame: 2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best overall response rate (ORR, CR and PR) within 18 weeks after registration [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Progression Free survival time (PFS), over complete observation period [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Overall Survival (OS) time [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index) [ Time Frame: 2010 ] [ Designated as safety issue: No ]
  • Safety and Tolerability [ Time Frame: 2010 ] [ Designated as safety issue: Yes ]

Enrollment: 67
Study Start Date: October 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMT2003 Drug: AMT2003

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.

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00405561

Locations
Germany
Clinic SanaFontis
Freiburg im Breisgau, Germany, 79111
Sponsors and Collaborators
Auron Healthcare GmbH
Investigators
Principal Investigator: Joachim Drevs, PD Dr. med. Clinic Sanafontis, Freiburg
  More Information

Additional Information:
now legally responsible for this study  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Auron Healthcare GmbH
ClinicalTrials.gov Identifier: NCT00405561     History of Changes
Other Study ID Numbers: AMT/P2GI/001 Part III, LC001Auron2005
Study First Received: November 29, 2006
Last Updated: March 19, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Auron Healthcare GmbH:
Advanced Colorectal Carcinoma

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013