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

Auron Healthcare

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Colorectal Carcinoma

Treatments

Drug: AMT2003

Study type

Interventional

Funder types

Industry

Identifiers

NCT00405561

AMT/P2GI/001 Part III

LC001Auron2005

Details and patient eligibility

About

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

Full 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.

Enrollment

67 patients

Sex

All

Ages

18 to 79 years old

Volunteers

No 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