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A Phase 2, Open-label, 2-arm, Response Rate Study Of Talazoparib In Men With Dna Repair Defects And Metastatic Castration-resistant Prostate Cancer Who Previously Received Taxane-based Chemotherapy And Progressed On At Least 1 Novel Hormonal Agent (Enzalutamide And/or Abiraterone Acetate/Prednisone)C3441006 - 2016-002036-32

Studio Clinico

Patologia: Carcinoma della prostata

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

  1. At least 18 years of age.
  2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features.
  3. Consent to a fresh tumor biopsy before enrollment unless adequate archival tissue is available for molecular analyses.
  4. DNA damage repair deficiency as assessed centrally by a gene mutation biomarker panel.
  5. Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.
  6. Serum testosterone ≤ 1.73 nmol/L (50 ng/dL) at screening.
  7. Bilateral orchiectomy or ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist (surgical or medical castration).
  8. Progressive disease at study entry defined as 1 or more of the following 3 criteria:

    • A minimum of 3 rising PSA values with an interval of at least 1 week between determinations. The screening central laboratory PSA value must be ≥ 2 μg/L (2 ng/mL) if qualifying solely by PSA progression.
    • Soft tissue disease progression as defined by RECIST 1.1.
    • Bone disease progression defined by PCWG3 with 2 or more new metastatic lesions on bone scan.
  9. Metastatic disease. Patients with disease spread limited to regional pelvic lymph nodes (below the aortic bifurcation) are not eligible unless bone metastasis is present on bone scan. Patients may also have metastatic disease documented by bone lesions on whole body radionuclide bone scan.
  10. Previous treatment with 1 or 2 chemotherapy regimens including at least 1 taxane-based regimen for metastatic prostate cancer. Patients may have received radium-223 and/or cabazitaxel, or were deemed unsuitable, declined, or did not have access to these therapies.
  11. A history of disease progression during previous treatment for metastatic CRPC with at least 1 novel hormonal therapy (enzalutamide and/or abiraterone acetate/prednisone) in the opinion of the investigator.
  12. Bisphosphonate or denosumab dosage must have been stable for at least 4 weeks before day 1 for patients receiving these therapies.
  13. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  14. Estimated life expectancy of ≥ 6 months as assessed by the investigator.

Criteri di esclusione: 

  1. Use of systemic hormonal, biologic, or radionuclide therapy for treatment of metastatic prostate cancer (other than approved bone-targeting agents and GnRH agonist/antagonist) or any other investigational agent within 4 weeks before day 1.
  2. Prior treatment with a PARP (poly ADP ribose polymerase) inhibitor, platinum, cyclophosphamide, or mitoxantrone chemotherapy.
  3. Radiation therapy within 3 weeks (within 2 weeks, if single fraction of radiotherapy) before day 1.
  4. Major surgery within 2 weeks before day 1.
  5. Clinically significant cardiovascular disease.
  6. Significant renal, hepatic, or bone marrow organ dysfunction.
  7. Known or suspected brain metastasis or active leptomeningeal disease.
  8. Symptomatic or impending spinal cord compression or cauda equina syndrome.
  9. Diagnosis of MDS (Myelodysplastic syndromes).
  10. History of another cancer within 3 years before enrollment with the exception of nonmelanoma skin cancers, or American Joint Committee on Cancer stage 0 or stage 1 cancer that has a remote probability of recurrence in the opinion of the investigator and the sponsor.
  11. Gastrointestinal disorder affecting absorption.
  12. Current or anticipated use of a strong P-gp inhibitor (eg, dronedarone, quinidine, ranolazine, itraconazole, ketoconazole), strong P-gp inducer (eg, rifampin, tipranavir, ritonavir), or strong inhibitor of BCRP (breast cancer resistance protein).l

Schema di trattamento: 

Talazoparib 1 mg daily

Trattamento sperimentale: 

Talazoparib

Trattamento di controllo: 

Talazoparib

Obiettivi primari dello studio: 

  • Objective Response Rate (ORR) [ Time Frame: Anticipated in about 34 months following first patient enrolled ]
The best ORR is defined as the proportion of patients in the ITT (intent-to-treat) population with a best overall soft tissue response of CR (complete response) or PR (partial response) per RECIST 1.1 by independent central review.

 

 

Centri partecipanti

Nord Italia

Ospedale Papa Giovanni XXIII Bergamo
Piazza OMS 1 - 24127 Bergamo - BG

 

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO

 

ASST di Cremona
Viale Concordia 1 - 26100 Cremona - CR

 

IRCCS - IRST
Via P. Maroncelli 40 - 47014 Meldola - FC

 

A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD

 

Azienda Ospedaliero-Universitaria di Parma
Via Gramsci 14 - 43126 Parma - PR

 

A.O.U San Luigi Gonzaga
Regione Gonzole 10 - 10043 Orbassano - TO

 

AOU Città della Salute e della Scienza di Torino
Corso Bramante 88 - 10126 Torino - TO

 

Ospedale dell'Angelo
Via Paccagnella 11 - 30121 Mestre - VE

 

Centro Italia

AOU Pisana - Santa Chiara
Via Roma 67 - 56126 Pisa - PI

 

Azienda Ospedaliera San Camillo Forlanini
Via Portuense 332 - 00149 Roma - RM
U.O. Oncologia Medica

Riferimento: Dr.ssa Cora Sternberg
Telefono: 0658704846
Email: csternberg@scamilloforlanini.rm.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: NCT03148795

Data di inserimento: 14.02.2018

Promotore

Pfizer

CRO

N.A.

Principal Investigator ITALIA

Azienda Ospedaliera San Camillo Forlanini

Riferimento: Dr.ssa Cora Sternberg

Telefono: 0658704846

Email: csternberg@scamilloforlanini.rm.it

Localita: Roma

 

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