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

Phase 2

Terminated

• Conditions: Colorectal Carcinoma
• Interventions: Drug: AMT2003

• Registration Number: NCT00405561
• Lead Sponsor: 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

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 Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-29
• Study First Submitted QC: 2006-11-29
• Study First Posted: 2006-11-30
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-19
• Last Update Posted: 2013-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 67

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMT2003	AMT2003	-

Primary Outcome Measures

Name	Time	Method
Progression free survival;at 18 weeks after registration	2010

Secondary Outcome Measures

Name	Time	Method
Best overall response rate (ORR, CR and PR) within 18 weeks after registration	2010
Progression Free survival time (PFS), over complete observation period	2010
Overall Survival (OS) time	2010
Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)	2010
Safety and Tolerability	2010

Trial Locations

Locations (1)

Clinic SanaFontis; 🇩🇪 Freiburg im Breisgau, Germany