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PUMA-NER-5201 - An Open-Label, Phase 2 Basket Study of Neratinib in Patients With Solid Tumors With Somatic Activating HER Mutations

Studio Clinico

Patologia: Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Terza/N linea

Criteri di inclusione: 

- Provide written informed consent
- Histologically confirmed cancers for which no curative therapy exists
- Documented HER2 or EGFR exon 18 mutation
- Participants must agree and commit to use appropriate methods of contraception as outlined in the protocol
- At least one measurable lesion, defined by RECIST v1.1

Criteri di esclusione: 

- Participants harboring ineligible somatic HER2 mutations
- Prior treatment with any HER2-directed tyrosine kinase inhibitor (e.g., lapatinib, afatinib, dacomitinib, neratinib) is excluded with the following exception: patients with EGFR exon 18 mutated NSCLC who may have received afatinib, osimertinib, or other pan HER or EGFR TKIs remain eligible
- Participants who are receiving any other anticancer agents
- Symptomatic or unstable brain metastases
- Women who are pregnant or breast-feeding
- There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

Schema di trattamento: 

Neratinib 240 mg una volta al giorno via orale

Neratinib 240 mg una volta al giorno via orale e Paclitaxel 80 mg/mq ev

Neratinib 240 mg una volta al giorno via orale e Fulvestrant 500 mg

Trattamento sperimentale: 

Neratinib
Fulvestrant
Trastuzumab

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

- Confirmed Objective Response Rate (Breast, Cervical Cohorts) [ Time Frame: From enrollment date to first confirmed Complete or Partial Response, whichever came earlier, up to 18 months ]
    Percentage of participants who are confirmed by independent central review to have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (HR+, HER2 negative metastatic breast cancer, and metastatic cervical cancer cohorts)

- Objective Response Rate - First Tumor Assessment (Other Cohorts) [ Time Frame: From enrollment date to first Complete or         Partial Response, whichever came earlier, up to 8 or 9 weeks ]
Percentage of participants who achieve CR or PR per RECIST v1.1, or other defined response criteria, at the first scheduled tumor assessment (all other cohorts)

Centri partecipanti

Nord Italia

ASST di Cremona
Viale Concordia 1 - 26100 Cremona - CR
S.C. Oncologia Medica

Riferimento: Dr. Rodolfo Passalascqua
Telefono: 0372405237
Email: segreteria.oncologia@asst-cremona.it

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI
Divisione Sviluppo Nuovi Farmaci per Terapie Innovative

Riferimento: Prof. Giuseppe Curigliano
Telefono: 0257489599
Email: giuseppe.curigliano@ieo.it

 

Sud Italia e isole

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2013-002872-42

Data di inserimento: 22.11.2016

Data di aggiornamento: 16.03.2021

Promotore

Puma Biotechnology, Inc.

CRO

Pivotal

Principal Investigator ITALIA

Istituti Ospitalieri Cremona

Riferimento: Dr. Rodolfo Passalacqua

Telefono: 0372405242

Email: passalacqua@ospedale.cremona.it

Localita: Cremona

 

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