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

Colorectal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00405561
• Other study ID #: AMT/P2GI/001 Part III
• Secondary ID: LC001Auron2005
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: November 29, 2006
• Last updated: March 19, 2013
• Start date: October 2006
• Est. completion date: January 2010

Study information

• Verified date: March 2013
• Source: Auron Healthcare GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Drug:
• AMT2003

Locations

Country	Name	City	State
Germany	Clinic SanaFontis	Freiburg im Breisgau

Sponsors (1)

Lead Sponsor	Collaborator
Auron Healthcare GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival;at 18 weeks after registration		2010	No
Secondary	Best overall response rate (ORR, CR and PR) within 18 weeks after registration		2010	No
Secondary	Progression Free survival time (PFS), over complete observation period		2010	No
Secondary	Overall Survival (OS) time		2010	No
Secondary	Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)		2010	No
Secondary	Safety and Tolerability		2010	Yes

External Links

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