A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

176

Participants

Timeline

Start Date

October 7, 2021

Primary Completion Date

February 28, 2028

Study Completion Date

May 30, 2028

Conditions
Ovarian Cancer
Interventions
DRUG

Ipatasertib

Ipatasertib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days)

DRUG

Cobimetinib

Cobimetinib will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length=28 days)

DRUG

Trastuzumab Emtansine

Trastuzumab Emtansine will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

DRUG

Atezolizumab

Atezolizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

DRUG

Bevacizumab

Bevacizumab will be administered intravenously on Day 1 of each cycle. (Cycle length=21 days)

DRUG

Paclitaxel

Paclitaxel will be administered intravenously on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)

DRUG

Giredestrant

Giredestrant will be administered by mouth once a day on Days 1-28 of each cycle (Cycle length=28 days)

DRUG

Abemaciclib

Abemaciclib will be administered by mouth twice a day during each 28-day cycle

DRUG

Inavolisib

Inavolisib will be administered by mouth once a day on Days 1-28 of each 28-day cycle

DRUG

Palbociclib

Palbociclib will be administered by mouth once a day on Days 1-21 of each 28-day cycle

DRUG

Letrozole

Letrozole will be administered by mouth once a day on Days 1-28 of each 28-day cycle

DRUG

Olaparib

Olaparib will be administered by mouth twice a day on Days 1-28 of each 28-day cycle

DRUG

Luteinizing Hormone-Releasing Hormone (LHRH) Agonists

LHRH agonists are required beginning at least 2 weeks prior to initiation of study treatment for premenopausal or perimenopausal women. Acceptable agents include goserelin or leuprolide; triptorelin is also acceptable. Monthly injections of LHRH agonist are preferred.

DRUG

Cyclophosphamide

Cyclophosphamide will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 21 days)

DRUG

Inavolisib

Inavolisib will be administered by mouth once a day on Days 1-21 of each 21-day cycle

Trial Locations (39)

1205

Hôpitaux Universitaires de Genève, Geneva

3144

Cabrini Hospital, Malvern

14076

Centre Francois Baclesse, Caen

20132

IRCCS S. Raffaele, Milan

23502

Virginia Oncology Associates, Norfolk

25030

CHU Besançon - Hôpital Jean Minjoz, Besançon

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

28204

Levine Cancer Institute, Charlotte

29010

Hospital Clinico Universitario Virgen de la Victoria, Málaga

31059

Institut Claudius Regaud, Toulouse

34010

Koc University Medical Faculty; Department of Gynecology & Obstetrics, Istanbul

35042

Centre Eugène Marquis, Rennes

43210

Ohio State University, Columbus

45136

Kliniken Essen-Mitte Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gynäkologische Onkologie, Essen

63108

Washington University School of Medicine, St Louis

68167

Universitätsklinikum Mannheim, Mannheim

69373

Centre Leon Berard, Lyon

70124

A.O. U. Consorziale Policlinico di Bari, Bari

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75020

Groupe Hospitalier Diaconesses, Paris

77380

Texas Oncology - Gulf Coast, The Woodlands

80131

Istituto Tumori Napoli, Napoli

94158

UCSF Helen Diller Family CCC, San Francisco

94800

Gustave Roussy, Villejuif

98109

University of Washington - Seattle Cancer Care Alliance, Seattle

M5G 1Z5

Princess Margaret Cancer Center, Toronto

H4A 3J1

McGill University Health Centre - Glen Site, Montreal

120 00

Gynekologicko-porodnicka klinika, Prague

00168

Policlinico Universitario Agostino Gemelli, Rome

(0)6351

Samsung Medical Center, Seoul

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

08908

Institutio Catalan De Oncologia, Barcelona

01220

Adana Baskent University Medical Faculty; Oncology, Adana

06490

Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü, Ankara

EH4 2XU

Western General Hospital, Edinburgh

NW1 2PG

University College London Hospitals NHS Foundation Trust - University College Hospital, London

All Listed Sponsors
collaborator

GOG Foundation

NETWORK

collaborator

European Network of Gynaecological Oncological Trial Groups (ENGOT)

OTHER

lead

Hoffmann-La Roche

INDUSTRY