A Phase 2 Study of Olaparib Monotherapy in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer - (MK7339-002 / LYNK-002)

Studio Clinico

Patologia: Neoplasie della mammella, Neoplasie del polmone, Neoplasie dello stomaco, Tumori del colon retto, Tumori dell’ovaio, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: II Randomizzato

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Non applicabile

Criteri di inclusione: 

• Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor (except breast or ovarian cancers whose tumor has a germline or somatic BRCA mutation) that is not eligible for curative treatment and for which standard of care therapy has failed. Participants must have progressed on or be intolerant to standard of care therapies that are known to provide clinical benefit. There is no limit on the number of prior treatment regimens.
• Has either centrally-confirmed known or suspected deleterious mutations in at least 1 of the genes involved in HRR or centrally-confirmed HRD.
• For participants receiving prior platinum (cisplatin, carboplatin, or oxaliplatin either as monotherapy or in combination) for advanced (metastatic and/or unresectable) solid tumor, have no evidence of disease progression during the platinum chemotherapy.
• Has measurable disease per RECIST 1.1 or PCWG-modified RECIST 1.1 as assessed by the local site Investigator/radiology and confirmed by BICR.
• Is able to provide a newly obtained core or excisional biopsy of a tumor lesion or either an archival formalin-fixed paraffin embedded (FFPE) tumor tissue block or slides.
• Has a life expectancy of at least 3 months.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within 3 days of treatment initiation.
• Male participants must agree to use contraception during the treatment period and for at least 90 days (3 months) after the last dose of study treatment and refrain from donating sperm during this period.
• Female participants must not be pregnant or breastfeeding. Additionally, female participants must either not be a woman of childbearing potential (WOCBP) or, if a WOCBP, agree to use contraception during the treatment period and for at least 30 days (1 month) after the last dose of study treatment.
• Has adequate organ function.

Criteri di esclusione: 

Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis

Trattamento sperimentale: 

Olaparib

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2018-003007-19

Data di inserimento: 01.10.2019

Promotore

Merck Sharp & Dohme Corp.

CRO

NA

Principal Investigator ITALIA

Istituto Clinico Humanitas, Rozzano (MI)

Riferimento: Prof. Armando Santoro

Telefono: 0282246280

Email: armando.santoro@cancercenter.humanitas.it

Localita: Rozzano (MI)