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Study of NGR-hTNF Administered at High Doses in Patient With Advanced or Metastatic Solid Tumour

NCT00878111 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-08-29

No results posted yet for this study

Summary

The main objective of the trial is to document the safety and antivascular effect of escalating doses of NGR-hTNF, from 60 mcg/sqm to 325 mcg/sqm, in patients affected by advanced or metastatic solid tumors not amenable of standard therapies.

Safety will be established by clinical and laboratory assessment according to NCI-CTCAE criteria (version 4.02).

Conditions

Interventions

DRUG

NGR-hTNF

First cohort: iv q3W 60 mcg/sqm over 120 min\* Second cohort: iv q3W 80 mcg/sqm over 120 min\* Third cohort: iv q3W 100 mcg/sqm over 120 min\* Fourth cohort: iv q3W 125 mcg/sqm over 120 min\* Fifth cohort: iv q3W 150 mcg/sqm over 120 min\* Sixth cohort: iv q3W 175 mcg/sqm over 120 min\* Seventh cohort: iv q3W 200 mcg/sqm over 120 min\* Eighth cohort: iv q3W 225 mcg/sqm over 120 min\* Ninth cohort: iv q3w 250 mcg/sqm over 120 min\* Tenth cohort: iv q3w 275 mcg/sqm over 120 min\* Eleventh cohort: iv q3w 300 mcg/sqm over 120 min\* Twelfth cohort: iv q3w 325 mcg/sqm over 120 min\* \* If the first infusion is well-tolerated, the second infusion may be delivered over 90 minutes. If the 90-minute infusion is well tolerated, all subsequent infusions may be delivered over a 60-minute period.

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
2009-04-30
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • Italy

Study Locations

More Related Trials

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 NCT00878111 on ClinicalTrials.gov