XXIX^ Riunione Nazionale MITO – Sessione Data Manager 21 Giugno 2017

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1 XXIX^ Riunione Nazionale MITO – Sessione Data Manager 21 Giugno 2017
“A randomized phase III trial of maintenance with Selinexor/ placebo after combination chemotherapy for patients with advanced or recurrent endometrial cancer.” BGOG-EN5-ENGOT-EN5 SIENDO Celeste Cagnazzo Clinical Research Office IRCCS Candiolo XXIX^ Riunione Nazionale MITO – Sessione Data Manager 21 Giugno 2017

2 SGCTG (Scottish Gynaecological Cancer Trials Group)
PARTICIPATING GROUPS Nordic Society of Gynecologic Oncology Francia Belgio, Sponsor Grecia Austria SGCTG (Scottish Gynaecological Cancer Trials Group) Scozia Svizzera Italia Germania

3 ITALIAN SITES Fondazione del Piemonte per l’Oncologia (Candiolo, PI: Valabrega) Istituto Nazionale Tumori IRCCS Fondazione Pascale (Napoli, PI: Pisano) Fondazione IRCCS Istituto Nazionale Tumori (Milano, PI: Lorusso) Policlinico Gemelli (Roma, PI: Scambia) IRST Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (Meldola, PI: De Giorgi) Sapienza Università di Roma (Roma, PI: Marchetti) Ospedale di Mirano (Mirano, PI: Artioli) Ospedale San Raffaele (Milano, PI: Mangili)

4 PD STUDY DESIGN Enrolled patients Oral Selinexor* 80 mg weekly
Patients: 126 (63 for each ARM) Placebo 80 mg weekly * a new oral novel agent, the first drug in a new class of agents known as Selective Inhibitor of Nuclear Export (SINE™) compounds. Selinexor works by inhibiting XPO1, a protein found in the nucleus of cancer cells, which activates tumor suppressors by retaining them in the nucleus of cancer cells. This results in apoptosis (death) of cancer cells, while largely sparing normal cells. Selinexor also reduces the levels of onco-proteins such as c-myc and bcl-2, thereby reducing the growth of cancer cells.

5 STUDY ENPOINTS Primary Secondary Progression Free Survival
Overall Survival

6 MAIN INCLUSION CRITERIA
- Histological confirmed endometrial cancer of the endometrioid, serous, or undifferentiated type. Carcinosarcoma of the uterus is also allowed. - Prior therapy Must have received paclitaxel-carboplatinum earlier. Second-line anthracycline based or again paclitaxel-carboplatin Hormonal treatment is allowed earlier. Patients with stage IV disease (FIGO 2009), who have completed first-line taxane-carboplatin combination at least 12 weeks and are in partial or complete remission according to RECIST 1.1, or Patients who have relapsed after primary therapy and have completed paclitaxel -carboplatin combination for at least 12 weeks (4 cycles of 3-or 4 weekly or 12 courses of weekly) for relapse and are in partial or complete remission according to RECIST 1.1, or Patients who have relapsed after primary therapy and have completed a paclitaxel-carboplatin combination and a second-line chemotherapy for at least 12 weeks for relapse and are in partial or complete remission according to RECIST 1.1. Prior adjuvant chemotherapy for Stage III or lower or neoadjuvant chemotherapy as first line treatment is counted as a line .

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8 STATUS Centro Coordinatore >>>>>>>>> approvato dal Comitato Scientifico (May 16) Centri Satellite >>>>>>>>> fattibilità inviate (16 Jun) Fondazione IRCCS Istituto Nazionale Tumori (Milano, PI: Lorusso) IRST Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (Meldola, PI: De Giorgi) Ospedale di Mirano (Mirano, PI: Artioli) Ospedale San Raffaele (Milano, PI: Mangili)