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NGR-hTNF Administered in Combination With a Standard Oxaliplatin Based Regimen in Patients With Metastatic Colorectal Cancer

NCT00675012 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-05-30

No results posted yet for this study

Summary

The main objective of the trial is to document the safety of NGR-hTNF administered at low and high doses in combination with a standard oxaliplatin based regimen in patients with metastatic colorectal cancer not amenable to any clinical improvement by current standard treatments

Conditions

Interventions

DRUG

NGR-hTNF

iv 0.8 or 45 mcg/sqm q3W

DRUG

Oxaliplatin

iv q3W 100 mg/sqm 60 minutes after NGR-hTNF infusion

DRUG

capecitabine

orally 825 mg/sqm 2qDx14

Sponsors & Collaborators

  • AGC Biologics S.p.A.

    lead INDUSTRY

Principal Investigators

  • Alberto Sobrero, MD · Azienda Ospedaliera Universitaria San Martino Genoa, Italy

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-12-31
Completion
2013-05-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00675012 on ClinicalTrials.gov