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Randomized, Double-Blind, Phase 2/3 Study in Subjects With Malignant Pleural Mesothelioma With Low Argininosuccinate Synthetase 1 Expression to Assess ADI-PEG 20 With Pemetrexed and Cisplatin - ATOMIC

Studio Clinico

Patologia: Mesotelioma

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: II Randomizzato, III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea

Criteri di inclusione: 

1.Histologically proven advanced MPM of biphasic or sarcomatoid histology. Biphasic MPM is defined using the World Health Organization's international histological classification of tumors as containing an epithelial and a sarcomatoid component with each component comprising at least 10% of the tumor
2.Naïve to prior chemotherapy or immunotherapy (i.e., this is a first-line systemic therapy study).
3.MPM tumor sample for determination of ASS1 status. ASS1-deficiency is not required for study entry at study start, but tumor sample for ASS1 status is required. This study will employ an adaptive biomarker-driven design with an interim analysis to be conducted at the end of the phase 2 portion. The interim analysis will evaluate the treatment effect of ADI PEG 20 in combination with pemetrexed and cisplatin on overall survival (OS) in the overall population (biphasic and sarcomatoid histology patients) and pre-defined subpopulation of biomarker-positive patients (ASS1-deficient subpopulation). Thus ASS1 deficiency may be required for the phase 3 portion of the study, pending the interim analysis. ASS1-deficiency, demonstrated on tissue specimen (cytospin samples are not acceptable), will be defined in the laboratory manual. If archived tissue is not sufficient or not available, then tissue must be obtained by biopsy.
4.Measurable disease as assessed by modified RECIST for MPM for thoracic disease (Appendix A) and RECIST 1.1 for extra-thoracic disease (Appendix B).
5.ECOG performance status of 0 - 1 (Appendix C).
6.Predicted life expectancy of at least 12 weeks.

Criteri di esclusione: 

1.Radiotherapy (except for palliative reasons) the previous two weeks before.
2.Ongoing toxic manifestations of previous treatments.
3.Symptomatic brain or spinal cord metastases (patients must be stable for > 1 month post radiotherapy or surgery).
4.Major thoracic or abdominal surgery from which the patient has not yet recovered.
5.Serious infection requiring treatment with intravenous antibiotics at the time of study entrance, or an infection requiring intravenous therapy within 7 days prior.
6.Known to be serologically positive for human immunodeficiency virus (HIV). Testing to determine possible infection status is not required.

Trattamento sperimentale: 

ADI-PEG 20+Cisplatino+Pemetrexed

Trattamento di controllo: 

Placebo+Cisplatino+Pemetrexed

Obiettivi primari dello studio: 

Response Rate [Time Frame: approximately 18 months]

Obiettivi secondari dello studio: 

Progression Free Survival [Time Frame: approximately 18 months]

Centri partecipanti

Nord Italia

SC Oncologia ASO SS Antonio e Biagio e C. Arrigo
Via Venezia 16 - 15100 Alessandria - AL

Riferimento: Dr.ssa Federica Grosso
Telefono: 0131206967
Email: federica.grosso@ospedale.al.it

 

Cliniche Humanitas Gavazzeni
Via Gavazzeni 21 - 24125 Bergamo - BG

Riferimento: Dr. Giovanni Luca Ceresoli
Telefono: 0354204500

 

Azienda Sanitaria 3 genovese - Villa Scassi
Corso Scassi 1 - 16149 Genova-Sanpierdarena - GE

Riferimento: Dr. Manlio Mencoboni
Email: manlio.mencoboni@asl3.liguria.it

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Prof. Filippo De Marinis
Telefono: 0257489773
Email: filippo.demarinis@ieo.it

 

A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB

Riferimento: Dr. Diego Cortinovis
Email: d.cortinovis@asst-monza.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT02709512

Data di inserimento: 29.10.2018

Data di aggiornamento: 02.05.2019

Promotore

Polaris Group

CRO

/

Principal Investigator ITALIA

Istituto Europeo di Oncologia, Milano

Riferimento: Prof. Filippo De Marinis

Telefono: 0257489773

Email: filippo.demarinis@ieo.it

Localita: Milano

Principal Investigator INTERNAZIONALE

Centre for Experimental Cancer Medicine (CECM)
Barts Cancer Institute (BCI) Queen Mary University of London Lower Ground Floor
Old Anatomy Building

Riferimento: Dr. Peter Szlosarek

Telefono: 02078823559

Email: p.w.szlosarek@qmul.ac.uk

Localita: London

Nazione: GB

 

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