NCT04729387 - Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected | Biotech Hunter

Enrollment

358

Participants

Timeline

Start Date

July 22, 2021

Primary Completion Date

April 21, 2023

Study Completion Date

December 5, 2025

Conditions

Ovarian Cancer

Interventions

DRUG

Alpelisib

Alpelisib will be administered at 200 mg orally once daily following food on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28-day cycle

DRUG

Olaparib

Olaparib will be administered at 200 mg orally twice daily irrespective of meals on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28-day cycle.

DRUG

Paclitaxel

Paclitaxel will be administered at 80 mg/m2 as an intravenous infusion weekly during a 28-day treatment cycle, starting on Cycle 1 Day 1, and on Day 8, Day 15 and Day 22 of every cycle thereafter

DRUG

Pegylated liposomal doxorubicin (PLD)

PLD will be administered at 40-50 mg/m2 (physician discretion) as an intravenous infusion once every 28-days in a 28 day treatment cycle, starting on Cycle 1 Day 1

Trial Locations (93)

1000

Novartis Investigative Site, Brussels

1230

Novartis Investigative Site, Adana

2031

Novartis Investigative Site, Sydney

3000

Novartis Investigative Site, Leuven

3630

Novartis Investigative Site, Shepparton

5000

Novartis Investigative Site, Namur

Novartis Investigative Site, Odense C

5041

Novartis Investigative Site, Bedford Park

6020

Novartis Investigative Site, Innsbruck

8036

Novartis Investigative Site, Graz

10002

Novartis Investigative Site, Taipei

10065

Memorial Sloan Kettering Cancer Ctr, New York

11217

Novartis Investigative Site, Taipei

13353

Novartis Investigative Site, Berlin

14004

Novartis Investigative Site, Córdoba

20133

Novartis Investigative Site, Milan

20141

Novartis Investigative Site, Milan

20904

Maryland Oncology Hematology P A, Silver Spring

25030

Novartis Investigative Site, Besançon

28034

Novartis Investigative Site, Madrid

31008

Novartis Investigative Site, Pamplona

33401

Florida Cancer Specialists, West Palm Beach

33901

Florida Cancer Specialists, Fort Myers

35575

Novartis Investigative Site, Izmir

36100

Novartis Investigative Site, Vicenza

37203

Sarah Cannon Research Institute, Nashville

40138

Novartis Investigative Site, Bologna

45136

Novartis Investigative Site, Essen

45242

Oncology Hematology Care Inc, Cincinnati

45267

University Of Cincinnati, Cincinnati

46010

Novartis Investigative Site, Valencia

50134

Novartis Investigative Site, Florence

50586

Novartis Investigative Site, Kuala Lumpur

57106

Avera Cancer Institute, Sioux Falls

59100

Novartis Investigative Site, Kuala Lumpur

64460

Novartis Investigative Site, Monterrey

68305

Novartis Investigative Site, Mannheim

69373

Novartis Investigative Site, Lyon

69495

Novartis Investigative Site, Pierre-Bénite

74101

Novartis Investigative Site, Nový Jičín

75012

Novartis Investigative Site, Paris

75246

Texas Oncology, Dallas

75702

Texas Oncology Northeast Texas, Tyler

76022

Texas Oncology P A, Bedford

78217

Texas Oncology P A, San Antonio

80131

Novartis Investigative Site, Napoli

83310

Novartis Investigative Site, Bratislava

85016

Arizona Oncology Associates, Phoenix

HonorHealth, Phoenix

88996

Novartis Investigative Site, Kota Kinabalu

93586

Novartis Investigative Site, Kuching

94800

Novartis Investigative Site, Villejuif

100036

Novartis Investigative Site, Beijing

119074

Novartis Investigative Site, Singapore

163045

Novartis Investigative Site, Arkhangelsk

168583

Novartis Investigative Site, Singapore

200032

Novartis Investigative Site, Shanghai

250012

Novartis Investigative Site, Jinan

300480

Novartis Investigative Site, Tianjin

407219

Novartis Investigative Site, Taichung

610041

Novartis Investigative Site, Chengdu

02114

Massachusetts General Hospital, Boston

02115

Dana Farber Cancer Institute, Boston

C1125ABD

Novartis Investigative Site, CABA

C1015ABO

Novartis Investigative Site, Ciudad Autonoma de Bs As

C1012AAR

Novartis Investigative Site, Buenos Aires

30130-100

Novartis Investigative Site, Belo Horizonte

04014-002

Novartis Investigative Site, São Paulo

T2N 5G2

Novartis Investigative Site, Calgary

V5Z 4E6

Novartis Investigative Site, Vancouver

N6A 5W9

Novartis Investigative Site, London

M4N 3M5

Novartis Investigative Site, Toronto

708 52

Novartis Investigative Site, Ostrava

128 08

Novartis Investigative Site, Prague

DK-2730

Novartis Investigative Site, Herlev

FIN-70211

Novartis Investigative Site, Kuopio

FIN-33521

Novartis Investigative Site, Tampere

FIN 20521

Novartis Investigative Site, Turku

01307

Novartis Investigative Site, Dresden

00168

Novartis Investigative Site, Roma

04700

Novartis Investigative Site, Mexico City

5623 EJ

Novartis Investigative Site, Eindhoven

2674-514

Novartis Investigative Site, Loures

4200-072

Novartis Investigative Site, Porto

03080

Novartis Investigative Site, Seoul

03722

Novartis Investigative Site, Seoul

08035

Novartis Investigative Site, Barcelona

08036

Novartis Investigative Site, Barcelona

06230

Novartis Investigative Site, Ankara

06520

Novartis Investigative Site, Ankara

G12 0YN

Novartis Investigative Site, Glasgow

SE1 9RT

Novartis Investigative Site, London

M20 2BX

Novartis Investigative Site, Manchester