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A Modified Phase I Study of NGR-hTNF in Advanced Solid Tumors

NCT00419328 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2022-07-21

No results posted yet for this study

Summary

The main objective of the trial is to explore the safety and biological activity of NGR-hTNF. The safety will be established by clinical and laboratory assessment. The biological activity will be evaluated by DCE-MRI with contrast media.

Conditions

Interventions

DRUG

NGR-hTNF

Drug: NGR-hTNF NGR-hTNF was administered every 3 weeks by a 1 hour intravenous iv infusion. NGR-hTNF in PBS was diluted in 0.9% NaCl, containing human serum albumin. Step 1: * starting dose: 0.2 μg/m2 * following doses: 0.4, 0.8 and 1.6 μg/m2. * number of patients: 4 per dose level Step 2: * starting dose: 3.2 μg/m2 * following doses: 6.4 and 12.8 μg/m2 * number of patients: 3 per dose level Step 3: * starting dose: 19.2 μg/m2 * following doses: 28.8, 43.2 and 64.8 μg/m2 * number of patients: 3 per dose level Step 4: * starting dose: 86.2 μg/m2 * following doses: 114.6 and 152.4 μg/m2 * number of patients: 3 per dose level

Sponsors & Collaborators

  • AGC Biologics S.p.A.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2007-09-30
Completion
2007-09-30

Countries

  • Italy

Study Locations

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Entities

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 NCT00419328 on ClinicalTrials.gov