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Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3) (ARIEL3)

Primary Purpose

Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rucaparib
Placebo
Sponsored by
pharmaand GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring ARIEL3, ARIEL 3, platinum sensitive, PARP Inhibitor, rucaparib, homologous recombination, homologous recombination deficiency, CO-338, PF 01367338, AG 14699, platinum sensitive ovarian cancer, platinum sensitive fallopian tube cancer, platinum sensitive primary peritoneal cancer, platinum sensitive peritoneal cancer, gynecological cancer, Clovis, Clovis Oncology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer.
  • Received ≥2 prior platinum-based treatment regimens including platinum based regimen that must have been administered immediately prior to maintenance therapy in this trial.
  • Received no more than 1 non-platinum chemotherapy regimen. Prior hormonal therapy will not be counted as a non-platinum regimen.
  • Must have had at least a 6-month disease-free period following prior treatment with the penultimate platinum-based chemotherapy and achieved a response.
  • For the last chemotherapy course prior to study entry, patients must have received a platinum-based doublet chemotherapy regimen and have achieved a CR or PR (as defined by RECIST) and/or a GCIG CA-125 response.
  • Have sufficient archival tumor tissue for analysis.

Exclusion Criteria:

  • History of prior cancer except for non-melanoma skin cancer, breast cancer curatively > 3 years ago, curatively treated solid tumor (>5 years ago without evidence of recurrence), and synchronous endometrial cancer (Stage 1A) with ovarian cancer.
  • Prior treatment with any PARP inhibitor, including rucaparib. Patients who received prior iniparib are eligible.
  • Untreated or symptomatic central nervous system metastases.
  • Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of study drug.
  • Required drainage of ascites during the final 2 cycles of their last platinum-based regimen and/or during the period between the last dose of chemotherapy of that regimen and randomization to maintenance treatment in this study.

Sites / Locations

  • University of Arizona Cancer Center
  • Saint Jude Heritage Medical Center
  • UC Davis Comprehensive Cancer Center
  • University of California San Francisco (UCSF)
  • Coastal Integrative Cancer Care
  • Central Coast Medical Oncology
  • University of California Los Angeles (UCLA)
  • Rocky Mountain Cancer Centers
  • Memorial Healthcare System
  • Sylvester Comprehensive Cancer Center
  • Florida Hospital
  • Johns Hopkins Universty
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Karmanos Cancer Institute - Wayne State University
  • Washington University School of Medicine - Division of Gynaecological Oncology
  • Memorial Sloan-Kettering Cancer Center
  • Hope Women's Cancer Centers
  • The Ohio State University Wexner Medical Center
  • University of Pennsylvania
  • University of Texas MD Anderson Cancer Center
  • University of Washington at Seattle
  • Prince of Wales Hospital
  • Westmead Hospital
  • Royal Brisbane & Women's Hospital
  • Flinders Medical Centre
  • Royal Melbourne Hospital
  • Sir Charles Gairdner Hospital
  • St John of God Hospital Subiaco
  • AZ St Augustinus
  • UZ Gent
  • UZ Leuven
  • Clinique Sainte-Elisabeth
  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • Juravinski Cancer Centre
  • London Regional Cancer Centre
  • Ottawa Hospital Cancer Centre
  • Princess Margaret Cancer Centre
  • CHUM Centre Hospitalier de l'Université de Montréal
  • Centre Hospitalier Universitaire de Québec
  • Centre Francois Baclesse
  • Institut Gustave Roussy
  • Hôpital Européen Georges-Pompidou
  • Institut Claudius Regaud
  • Centre Catherine de Sienne
  • Centre Leon Berard
  • Centre Hospitalier Lyon Sud
  • Institute Bergonie
  • Hospital Tenon
  • Klinikum Stuttgart
  • Klinikum Ludwigsburg-Bietigheim gGmbH
  • Rotkreuzklinikum Muenchen gGmbH
  • Universitätsklinikum Frankfurt
  • Dr. Horst Schmidt Klinik, Klinik fuer Gynaekologie und Gyn. Onkologie
  • Klinikum Chemnitz gGmbH
  • Technische Universität Dresden
  • Rambam Health Care Campus
  • Lady Davis Carmel Medical Center
  • Rabin Medical Center
  • Oncology Institute, Sheba Medical Center
  • Sourasky Medical Center
  • Assaf Harofeh M.C.
  • Oncology Unit City Hospital degli Infermi
  • Arcispedale Santa Maria Nuova IRCCS
  • Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
  • Fondazione IRCCS National Cancer Institute
  • Instituto Europeo di Oncologia
  • Azienda Ospedaliero Universitaria Policlinico di Modena
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale
  • Policlinico Universitario Agostino Gemelli
  • Auckland City Hospital
  • Palmsteron North Hospital
  • Wellington Hospital
  • Hospital Central de Asturias
  • Centro Oncologico de Galica
  • Hospital Vall D'Hebron
  • Hospital Ramón y Cajal
  • Hospital Universitario San Carlos
  • Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
  • Hospital Regional Universitario Carlos Haya de Malaga
  • Hospital Universitario Virgen del Rocío
  • Instituto Valencia de Oncologia-Fundacion
  • Hospital Clinico Universitario de Valencia
  • Royal Marsden Hospital
  • Belfast City Hospital
  • Beatson West of Scotland Cancer Centre
  • The Royal Marsden NHS Foundation Trust
  • St. James University Hospital
  • Addenbrookes Hospital
  • Barts Health NHS Trust
  • Imperial College Healthcare NHS Trust
  • Sarah Cannon Reserach Institute UK
  • University College London
  • The Christie NHS Foundation Trust
  • Sir Bobby Robson Cancer trials research Centre, Northern Centre For Cancer Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rucaparib

Placebo

Arm Description

Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.

Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.

Outcomes

Primary Outcome Measures

Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS)
Progression-free survival by Investigator (invPFS) is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Secondary Outcome Measures

Disease Progression According to RECIST v1.1, as Assessed by Independent Radiology Review (IRR), or Death From Any Cause (irrPFS)
To evaluate PFS by RECIST v1.1, as assessed by independent radiology review (IRR).
Overall Survival (OS)
Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive.
Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18
The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related symptoms and is based on numerical point scoring of symptoms. The DRS-P subscale of the questionnaire is specifically designed to assess physical symptoms of ovarian cancer and evaluate changes in the subscale point score in individual assessments over time. This study looked at the time to a 4-point reduction in subscale score as an indicator of improvement in disease-related physical symptoms on cancer therapy.
Time to an 8-point Decrease in the Total Score of the FOSI-18
The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related physical, emotional and treatment-related symptoms, and is based on numerical point scoring of symptoms. The questionnaire is designed to evaluate changes in the total score in individual assessments over time. This study looked at the time to an 8-point reduction in the total score as an indicator of improvement in disease-related symptoms on cancer therapy.
Individual Model Parameter Estimates of Rucaparib and Covariates Identification
Concentration summary statistics

Full Information

First Posted
October 17, 2013
Last Updated
June 7, 2023
Sponsor
pharmaand GmbH
Collaborators
Foundation Medicine, Myriad Genetics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01968213
Brief Title
Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)
Acronym
ARIEL3
Official Title
A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer ( ARIEL3 )
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 7, 2014 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
July 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
pharmaand GmbH
Collaborators
Foundation Medicine, Myriad Genetics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to evaluate patient response to maintenance treatment with rucaparib versus placebo. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.
Detailed Description
Rucaparib is an orally available, small molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) being developed for treatment of ovarian cancer associated with homologous recombination (HR) DNA repair deficiency (HRD). Clinical data have shown that ovarian cancer patients with and without evidence of a gBRCA mutation benefit from treatment with a PARP and that maintenance treatment with a PARP inhibitor following a response to platinum-based treatment increases PFS in patients with ovarian cancer. While patients with a BRCA mutation derived the most benefit, patients without evidence of a BRCA mutation also derived significant benefit. Patients enrolled into this study will be stratified into 3 groups based on tumor HRD status. The purpose of this study is to identify which of these groups of patients will most likely benefit from treatment with rucaparib. It is anticipated that rucaparib will provide therapeutic benefit and increase PFS in patients with HRD associated with a BRCA gene mutation or other HR gene alteration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Keywords
ARIEL3, ARIEL 3, platinum sensitive, PARP Inhibitor, rucaparib, homologous recombination, homologous recombination deficiency, CO-338, PF 01367338, AG 14699, platinum sensitive ovarian cancer, platinum sensitive fallopian tube cancer, platinum sensitive primary peritoneal cancer, platinum sensitive peritoneal cancer, gynecological cancer, Clovis, Clovis Oncology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
564 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rucaparib
Arm Type
Experimental
Arm Description
Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.
Intervention Type
Drug
Intervention Name(s)
Rucaparib
Other Intervention Name(s)
CO-338, PF 01367338, AG 14699
Intervention Description
Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.
Primary Outcome Measure Information:
Title
Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS)
Description
Progression-free survival by Investigator (invPFS) is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).
Time Frame
Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.
Secondary Outcome Measure Information:
Title
Disease Progression According to RECIST v1.1, as Assessed by Independent Radiology Review (IRR), or Death From Any Cause (irrPFS)
Description
To evaluate PFS by RECIST v1.1, as assessed by independent radiology review (IRR).
Time Frame
Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 8.2 years.
Title
Overall Survival (OS)
Description
Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive.
Time Frame
All patients were followed for survival up to approximately 8.2 years.
Title
Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18
Description
The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related symptoms and is based on numerical point scoring of symptoms. The DRS-P subscale of the questionnaire is specifically designed to assess physical symptoms of ovarian cancer and evaluate changes in the subscale point score in individual assessments over time. This study looked at the time to a 4-point reduction in subscale score as an indicator of improvement in disease-related physical symptoms on cancer therapy.
Time Frame
Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years.
Title
Time to an 8-point Decrease in the Total Score of the FOSI-18
Description
The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related physical, emotional and treatment-related symptoms, and is based on numerical point scoring of symptoms. The questionnaire is designed to evaluate changes in the total score in individual assessments over time. This study looked at the time to an 8-point reduction in the total score as an indicator of improvement in disease-related symptoms on cancer therapy.
Time Frame
Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years.
Title
Individual Model Parameter Estimates of Rucaparib and Covariates Identification
Description
Concentration summary statistics
Time Frame
Study data collection occurred over approximately 7 months.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer. Received ≥2 prior platinum-based treatment regimens including platinum based regimen that must have been administered immediately prior to maintenance therapy in this trial. Received no more than 1 non-platinum chemotherapy regimen. Prior hormonal therapy will not be counted as a non-platinum regimen. Must have had at least a 6-month disease-free period following prior treatment with the penultimate platinum-based chemotherapy and achieved a response. For the last chemotherapy course prior to study entry, patients must have received a platinum-based doublet chemotherapy regimen and have achieved a CR or PR (as defined by RECIST) and/or a GCIG CA-125 response. Have sufficient archival tumor tissue for analysis. Exclusion Criteria: History of prior cancer except for non-melanoma skin cancer, breast cancer curatively > 3 years ago, curatively treated solid tumor (>5 years ago without evidence of recurrence), and synchronous endometrial cancer (Stage 1A) with ovarian cancer. Prior treatment with any PARP inhibitor, including rucaparib. Patients who received prior iniparib are eligible. Untreated or symptomatic central nervous system metastases. Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of study drug. Required drainage of ascites during the final 2 cycles of their last platinum-based regimen and/or during the period between the last dose of chemotherapy of that regimen and randomization to maintenance treatment in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Giordano
Organizational Affiliation
Clovis Oncology, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Saint Jude Heritage Medical Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California San Francisco (UCSF)
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Coastal Integrative Cancer Care
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93422
Country
United States
Facility Name
Central Coast Medical Oncology
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
University of California Los Angeles (UCLA)
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Memorial Healthcare System
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Johns Hopkins Universty
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Institute - Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University School of Medicine - Division of Gynaecological Oncology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Hope Women's Cancer Centers
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington at Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Prince of Wales Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
St John of God Hospital Subiaco
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
608
Country
Australia
Facility Name
AZ St Augustinus
City
Antwerpen
ZIP/Postal Code
2610
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Clinique Sainte-Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1Z2
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V5C2
Country
Canada
Facility Name
London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A4L6
Country
Canada
Facility Name
Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
CHUM Centre Hospitalier de l'Université de Montréal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L4M1
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Québec
City
Quebec
ZIP/Postal Code
G1R2J6
Country
Canada
Facility Name
Centre Francois Baclesse
City
Caen Cedex 05
State/Province
Basse-Normandie
ZIP/Postal Code
14076
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
State/Province
Ile De France
ZIP/Postal Code
94805
Country
France
Facility Name
Hôpital Européen Georges-Pompidou
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75908
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
State/Province
Midi-Pyrenees
ZIP/Postal Code
31052
Country
France
Facility Name
Centre Catherine de Sienne
City
Nantes Cedex
State/Province
Pays De La Loire
ZIP/Postal Code
44202
Country
France
Facility Name
Centre Leon Berard
City
Lyon
State/Province
Rhone-Alpes
ZIP/Postal Code
69373
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
State/Province
Rhone-Alpes
ZIP/Postal Code
69495
Country
France
Facility Name
Institute Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hospital Tenon
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Klinikum Stuttgart
City
Stuttgart
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
70174
Country
Germany
Facility Name
Klinikum Ludwigsburg-Bietigheim gGmbH
City
Ludwigsburg
State/Province
Baden-Wuerttembert
ZIP/Postal Code
71640
Country
Germany
Facility Name
Rotkreuzklinikum Muenchen gGmbH
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80637
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
Dr. Horst Schmidt Klinik, Klinik fuer Gynaekologie und Gyn. Onkologie
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65199
Country
Germany
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09116
Country
Germany
Facility Name
Technische Universität Dresden
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Lady Davis Carmel Medical Center
City
Haifa
Country
Israel
Facility Name
Rabin Medical Center
City
Petach-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Oncology Institute, Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Assaf Harofeh M.C.
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Oncology Unit City Hospital degli Infermi
City
Faenza
State/Province
Ravenna
ZIP/Postal Code
48018
Country
Italy
Facility Name
Arcispedale Santa Maria Nuova IRCCS
City
Reggio Emilia
State/Province
Reggio Nella Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Fondazione IRCCS National Cancer Institute
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Instituto Europeo di Oncologia
City
Milan
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico di Modena
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00158
Country
Italy
Facility Name
Auckland City Hospital
City
Auckland
State/Province
Grafton
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Palmsteron North Hospital
City
Palmerston North
State/Province
Manawatu
ZIP/Postal Code
4442
Country
New Zealand
Facility Name
Wellington Hospital
City
Newtown
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Hospital Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Centro Oncologico de Galica
City
A Coruna
ZIP/Postal Code
15009
Country
Spain
Facility Name
Hospital Vall D'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya de Malaga
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Instituto Valencia de Oncologia-Fundacion
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Royal Marsden Hospital
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Belfast City Hospital
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G120YN
Country
United Kingdom
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
St. James University Hospital
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS97TF
Country
United Kingdom
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB20QQ
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
EC1M6BQ
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W120HS
Country
United Kingdom
Facility Name
Sarah Cannon Reserach Institute UK
City
London
ZIP/Postal Code
W1G6AD
Country
United Kingdom
Facility Name
University College London
City
London
ZIP/Postal Code
W1T4TJ
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M204BX
Country
United Kingdom
Facility Name
Sir Bobby Robson Cancer trials research Centre, Northern Centre For Cancer Care
City
Newcastle Upon Tyne
ZIP/Postal Code
NE77DN
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35397664
Citation
Green ML, Ma SC, Goble S, Giordano H, Maloney L, Simmons AD, Beltman J, Harding TC, Xiao JJ. Population pharmacokinetics of rucaparib in patients with advanced ovarian cancer or other solid tumors. Cancer Chemother Pharmacol. 2022 May;89(5):671-682. doi: 10.1007/s00280-022-04413-7. Epub 2022 Apr 10.
Results Reference
derived
PubMed Identifier
35170751
Citation
Tattersall A, Ryan N, Wiggans AJ, Rogozinska E, Morrison J. Poly(ADP-ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database Syst Rev. 2022 Feb 16;2(2):CD007929. doi: 10.1002/14651858.CD007929.pub4.
Results Reference
derived
PubMed Identifier
32861537
Citation
Colombo N, Oza AM, Lorusso D, Aghajanian C, Oaknin A, Dean A, Weberpals JI, Clamp AR, Scambia G, Leary A, Holloway RW, Gancedo MA, Fong PC, Goh JC, O'Malley DM, Armstrong DK, Banerjee S, Garcia-Donas J, Swisher EM, Meunier J, Cameron T, Maloney L, Goble S, Bedel J, Ledermann JA, Coleman RL. The effect of age on efficacy, safety and patient-centered outcomes with rucaparib: A post hoc exploratory analysis of ARIEL3, a phase 3, randomized, maintenance study in patients with recurrent ovarian carcinoma. Gynecol Oncol. 2020 Oct;159(1):101-111. doi: 10.1016/j.ygyno.2020.05.045. Epub 2020 Aug 26.
Results Reference
derived
PubMed Identifier
32359490
Citation
Ledermann JA, Oza AM, Lorusso D, Aghajanian C, Oaknin A, Dean A, Colombo N, Weberpals JI, Clamp AR, Scambia G, Leary A, Holloway RW, Gancedo MA, Fong PC, Goh JC, O'Malley DM, Armstrong DK, Banerjee S, Garcia-Donas J, Swisher EM, Cameron T, Maloney L, Goble S, Coleman RL. Rucaparib for patients with platinum-sensitive, recurrent ovarian carcinoma (ARIEL3): post-progression outcomes and updated safety results from a randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2020 May;21(5):710-722. doi: 10.1016/S1470-2045(20)30061-9.
Results Reference
derived
PubMed Identifier
28916367
Citation
Coleman RL, Oza AM, Lorusso D, Aghajanian C, Oaknin A, Dean A, Colombo N, Weberpals JI, Clamp A, Scambia G, Leary A, Holloway RW, Gancedo MA, Fong PC, Goh JC, O'Malley DM, Armstrong DK, Garcia-Donas J, Swisher EM, Floquet A, Konecny GE, McNeish IA, Scott CL, Cameron T, Maloney L, Isaacson J, Goble S, Grace C, Harding TC, Raponi M, Sun J, Lin KK, Giordano H, Ledermann JA; ARIEL3 investigators. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Oct 28;390(10106):1949-1961. doi: 10.1016/S0140-6736(17)32440-6. Epub 2017 Sep 12. Erratum In: Lancet. 2017 Oct 28;390(10106):1948.
Results Reference
derived
Links:
URL
http://www.arielstudy.com
Description
ARIEL program website

Learn more about this trial

Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)

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