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

November 29, 2006
March 19, 2013
October 2006
January 2010   (final data collection date for primary outcome measure)
Progression free survival;at 18 weeks after registration [ Time Frame: 2010 ] [ Designated as safety issue: No ]
Progression free survival;at 18 weeks after registration
Complete list of historical versions of study NCT00405561 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Study to Evaluate Progression Free Survival in Cancer Patients With Advanced Colorectal Carcinoma With AMT2003
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

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

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.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Carcinoma
Drug: AMT2003
Experimental: AMT2003
Intervention: Drug: AMT2003
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
67
January 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00405561
AMT/P2GI/001 Part III, LC001Auron2005
Not Provided
Auron Healthcare GmbH
Auron Healthcare GmbH
Not Provided
Principal Investigator: Joachim Drevs, PD Dr. med. Clinic Sanafontis, Freiburg
Auron Healthcare GmbH
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP