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Study of NGR-hTNF in Combination With Cisplatin in Solid Tumor

NCT00483093 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

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 the combination (escalation doses of NGR-hTNF, from 0.2 mcg/sqm to 1.6 mcg/sqm , with a fixed dose of cisplatin, 80 mg/sqm). Safety will be established by clinical and laboratory assessment according to National Cancer Institute Common Toxicity Criteria (NCI-CTC ).

Conditions

Interventions

DRUG

NGR-hTNF

iv q3W escalating dose NGR-hTNF up to 1.6 mcg/sqm

DRUG

Cisplatin

iv q3W 80 mg/sqm 30 minutes after NGR-hTNF infusion for a maximum of six cycles

Sponsors & Collaborators

  • AGC Biologics S.p.A.

    lead INDUSTRY

Principal Investigators

  • Antonio Lambaise, MD · AGC Biologics S.p.A.

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
2007-07-31
Primary Completion
2010-06-30
Completion
2013-04-30

Countries

  • Italy

Study Locations

More Related Trials

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 NCT00483093 on ClinicalTrials.gov