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

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00405561

Enrollment

Registered

2006-11-30

Start date

2006-10-31

Completion date

2010-01-31

Last updated

2013-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Carcinoma

Keywords

Advanced Colorectal Carcinoma

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.

Interventions

DRUGAMT2003

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Progression free survival;at 18 weeks after registration	2010

Secondary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026