A Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer|
- Phase I: Maximum tolerated Dose [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]Establishment of the maximum tolerated dose (MTD), a recommended dose (RD) for the phase II part, and the safety of dosimetric and therapeutic administration of escalating dosages of the human radiolabeled antibody 131I-F16SIP.
- Phase II: Antitumour activity [ Time Frame: 14 months ] [ Designated as safety issue: No ]Investigation of the antitumour activity of 131I-F16SIP at the RD.
- Phase I: Study of the variation of radioactivity of 131I or 124I in whole blood, at several time intervals (Pharmacokinetics) [ Time Frame: 2 days ] [ Designated as safety issue: No ]Evaluation of the pharmacokinetics of 131I-F16SIP and 124I-F16SIP.
- Phase II: Adverse Events as a Measure of Safety [ Time Frame: 30 days/ administration ] [ Designated as safety issue: Yes ]Determination of the overall safety profile of the iodinated antibody characterized by type, frequency, severity, timing and relationship to study therapy of adverse events and laboratory abnormalities in the first and eventual following administrations in all patients receiving a therapeutic dose.
- Phase II: Overall Response Rate (ORR) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Evaluation of the overall Response Rate (ORR) for all patients having received a therapeutic dose.
- Phase II: Progression free survival (PFS) [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Evaluation of the progression free survival (PFS) for all patients having received a therapeutic dose.
- Phase II: Survival rate [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Evaluation of the survival rate at 6 and 12 months and overall survival time for all patients having received a therapeutic dose.
|Study Start Date:||September 2008|
|Study Completion Date:||April 2013|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Phase I: Multicentre, open-label, two-step singlearm dose escalation study in sequential cohorts of patients with cancer.
Phase II: Prospective, open-label, single-arm, multicentre study of 131I-F16SIP, given at the RD of 55.5 mCi/m2, as determined in phase I.
Drug: 131I-F16SIP Radioimmunotherapy (RIT)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240720
|University Hospital Pisa|
|Pisa, Tuscany, Italy, 56126|
|Policlinico S. Orsola-Malpighi- Azienda Ospedaliero-Universitaria di Bologna|
|ASUR Zona Territoriale 9, Medicina Nucleare Ospedale di Macerata|
|Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Meldola (Fc)|
|Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale Di Napoli|
|Arcispedale Santa Maria Nuova Di Reggio Emilia|
|Reggio Emilia, Italy|
|Principal Investigator:||Maddalena Sansovini, Dr||IRST - ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI|