MedTrace Logo

A Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer

NCT01240720 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2014-02-25

No results posted yet for this study

Summary

The aim of this Study Protocol is to provide a basis for the clinical development of 131I-F16SIP as an anti-cancer therapeutic agent.

The study follows and is greatly motivated by the promising results of a Phase I/II study with a similar investigational drug developed by our Company, 131I-L19SIP, in several Italian centers.

Conditions

Interventions

DRUG

131I-F16SIP Radioimmunotherapy (RIT)

* Dosimetric evaluation with 131I-F16SIP or 124I-F16SIP will be performed to assess eligibility for Radioimmunotherapy. * Patients eligible for Radioimmunotherapy will receive 55.5 mCi/m2 as established in the Phase I part of the study. A single dose of 5 to 10 mg of 131I-F16SIP will be administered intravenously (I.V).

Sponsors & Collaborators

  • Eudax S.r.l.

    collaborator INDUSTRY

  • Philogen S.p.A.

    lead INDUSTRY

Principal Investigators

  • Maddalena Sansovini, Dr · IRST (Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori)

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
2008-09-30
Primary Completion
2011-11-30
Completion
2013-04-30

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 NCT01240720 on ClinicalTrials.gov