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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00405561
Recruitment Status : Terminated (Lack of efficacy)
First Posted : November 30, 2006
Last Update Posted : March 20, 2013
Information provided by (Responsible Party):
Auron Healthcare GmbH

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

Condition or disease Intervention/treatment Phase
Colorectal Carcinoma Drug: AMT2003 Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Experimental: AMT2003 Drug: AMT2003

Primary Outcome Measures :
  1. Progression free survival;at 18 weeks after registration [ Time Frame: 2010 ]

Secondary Outcome Measures :
  1. Best overall response rate (ORR, CR and PR) within 18 weeks after registration [ Time Frame: 2010 ]
  2. Progression Free survival time (PFS), over complete observation period [ Time Frame: 2010 ]
  3. Overall Survival (OS) time [ Time Frame: 2010 ]
  4. Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index) [ Time Frame: 2010 ]
  5. Safety and Tolerability [ Time Frame: 2010 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00405561

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

Additional Information:
Responsible Party: Auron Healthcare GmbH Identifier: NCT00405561     History of Changes
Other Study ID Numbers: AMT/P2GI/001 Part III
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013

Keywords provided by Auron Healthcare GmbH:
Advanced Colorectal Carcinoma

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