Back to resultsA Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2) (ARIEL2)
Primary Purpose
Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Oral rucaparib
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring ovarian cancer, fallopian tube cancer, primary peritoneal cancer, peritoneal cancer, platinum sensitive, relapsed disease, PARP Inhibitor, rucaparib, homologous recombination, homologous recombination deficiency, genomic scarring, loss of heterozygosity, 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, ARIEL2, ARIEL 2, ARIEL3, ARIEL 3
Eligibility Criteria
The following eligibility criteria pertain to patients enrolling into PART 2 of the study:
Inclusion:
- Have a histologically confirmed diagnosis of high grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Received at least 3 prior chemotherapy regimens. Non-chemotherapy regimens and maintenance therapies administered as single agent treatment will not count as a chemotherapy regimen
- Relapsed/progressive disease as confirmed by CT scan
- Have biopsiable and measurable disease. Note: biopsy is optional for patients known to harbor a deleterious gBRCA mutation
- Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses
Exclusion:
- History of prior cancers except for those that have been curatively treated, with no evidence of cancer currently (provided all chemotherapy was completed >6 months prior and/or bone marrow transplant >2 years prior to first dose of rucaparib).
- Prior treatment with any PARP inhibitor
- Symptomatic and/or untreated central nervous system metastases
- Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib
- Hospitalization for bowel obstruction within 3 months prior to enrollment
Sites / Locations
- Providence Alaska Medical Center
- University of Arizona Cancer Center
- Saint Jude Heritage Medical Center
- University of California Los Angeles
- UC San Diego
- California Pacific Medical Center
- University of California, San Francisco
- Coastal Integrative Cancer Care
- Central Coast Medical Oncology
- Stanford University
- Rocky Mountain Cancer Centers
- Mayo Clinic Jacksonville
- Altus Research
- University of Miami Hospital & Clinics Sylvester Comprehensive Cancer Center
- Florida Hospital Cancer Institute
- UF Health Cancer Center
- Horizon BioAdvance
- Norton Cancer Institute
- Johns Hopkins Kimmel Cancer Center
- Massachusetts General Hospital
- Dana-Farber Cancer Institute
- Mayo Clinic
- Washington University School of Medicine
- Comprehensive Cancer Centers of Nevada
- Women's Cancer Care Associates
- New York University Langone Medical Center
- Memorial Sloan-Kettering Cancer Center
- Hope - A Woman's Cancer Institute
- University of Cincinnati Physicians Company
- The Ohio State University Wexner Medical Center
- University of Oklahoma
- University of Pennsylvania
- Fox Chase Cancer Center
- UPMC Cancer Center
- The University of Texas MD Anderson Cancer Center
- University of Washington - Seattle Cancer Care Alliance
- Royal North Shore Hospital
- Prince of Wales Hospital
- Royal Brisbane & Women's Hospital
- Flinders Cancer Clinic - Flinders Medical Centre (FMC)
- Mercy Hospital for Women
- Royal Melbourne Hospital
- Crown Princess Mary Cancer Centre (Westmead Hospital)
- Charles Gairdner Hospital
- Tom Baker Cancer Centre
- Cross Cancer Centre
- British Columbia Cancer Agency
- BC Cancer Agency - Fraser Valley Centre
- Vancouver Cancer Centre, British Columbia Cancer Agency (BCCA)
- London Regional Cancer Centre
- Ottawa Hospital Cancer Centre
- Princess Margaret Cancer Centre
- Centre Hospitalier de L'Universite de Montreal
- Jewish General Hospital
- CHU de Québec - Université Laval
- Institut Bergonie
- Hopital Tenon
- Hôpital Européen Georges-Pompidou
- Institut de cancerologie Gustave Roussy
- Institut Claudius Regaud
- Centre Catherine de Sienne
- Centre Leon Berard
- Centre Hospitalier Lyon Sud
- Hospital Vall d'Hebron
- Instituto Valencia de Oncologia
- Hospital Clinico Universitario de Valencia
- Beatson West of Scotland Cancer Centre
- Royal Marsden Sutton Hospital
- St James University Hospital
- Addenbrooke's Hospital
- Royal Marsden NHS Foundation Trust
- Imperial College Healthcare NHS Trust - Hammersmith Hospital
- 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 Type
Experimental
Arm Label
Ovarian cancer
Arm Description
rucaparib
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study)
The primary efficacy endpoint of PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST (Response Evaluation Criteria in Solid Tumors), as determined by the investigator or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study)
The confirmed response rate by RECIST v1.1 is defined as the percentage of patients with a confirmed complete response (CR) or partial response (PR) on subsequent tumor assessment at least 28 days after first response documentation. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Secondary Outcome Measures
Objective Response Rate (ORR) by RECIST v1.1 (Part 1 of Study)
The confirmed response rate by RECIST v1.1 is defined as the percentage of patients with a confirmed CR or PR on subsequent tumor assessment at least 28 days after first response documentation. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Objective Response Rate (ORR) by RECIST v1.1 and GCIG CA-125 Criteria
The endpoint of ORR defined as the percentage of patients with a best response of CR or PR using RECIST v 1.1 or a response per Gynecologic Cancer InterGroup cancer antigen 125 (GCIG CA-125) criteria. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. A response to CA-125 has occurred if there is at least a 50% decrease from baseline: 1. in a sample collected after initiation of study treatment AND 2. that is confirmed in a subsequent sample collected ≥21 days after the prior sample. The absolute value of this confirmatory sample must be ≤110% of the prior sample. The date when the first sample with a 50% decrease from baseline is observed is the date of the CA-125 response.
Duration of Response Per RECIST v1.1
Duration of response (DOR) for any confirmed RECIST CR or PR measured from the date of the first occurrence of a response until the first occurrence of progressive disease (PD) per RECIST. For patients who continued treatment post-progression, the first date of progression was used for the analysis. Any patients with an ongoing response were censored at the date of the last post-baseline scan. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study)
Progression-Free Survival (PFS) is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
Overall Survival (Part 2 of Study)
Overall survival (OS) is defined as the number of days from the date of first dose of study drug to the date of death (due to any cause). Patients without a known date of death will be censored on the date the patient was last known to be alive.
Steady State Trough (Cmin) Level Rucaparib Concentrations
Per protocol, the secondary PK endpoint, trough (Cmin) concentrations of rucaparib were summarized with descriptive statistics overall and by cycle in all patients with at least one PK sample collected. Blood samples for trough level PK analysis of rucaparib were drawn at the following timepoints only: on Day 15 of Cycle 1 and on Day 1 of Cycles 2, 3, and 4. Data for other timepoints is not available.
Full Information
NCT ID
NCT01891344
First Posted
June 20, 2013
Last Updated
June 7, 2023
Sponsor
pharmaand GmbH
Collaborators
Foundation Medicine, Myriad Genetics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01891344
Brief Title
A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Acronym
ARIEL2
Official Title
A Phase 2, Open-Label Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 30, 2013 (Actual)
Primary Completion Date
November 5, 2019 (Actual)
Study Completion Date
September 28, 2021 (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
No
5. Study Description
Brief Summary
The purpose of this study is to determine which patients with ovarian, fallopian tube, and primary peritoneal cancer will best respond to treatment with rucaparib.
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). The safety and efficacy of rucaparib has been evaluated in several Phase 1 and Phase 2 studies. An oral formulation is the focus of current development efforts. Rucaparib is currently being investigated as monotherapy in patients with cancer associated with breast cancer susceptibility gene 1 (BRCA1) or BRCA2 mutations.
Clinical data with PARP inhibitors indicate there is an ovarian cancer patient population beyond just those with germline BRCA (gBRCA) mutations that may benefit from treatment with a PARP inhibitor. This study will define a molecular signature of HRD in ovarian cancer that correlates with response to rucaparib and enables selection of appropriate ovarian cancer patients for treatment with rucaparib. The HRD signature will be based on an association between the extent of genomic scarring (a downstream consequence of HRD) in a patient's tumor and observed clinical benefit from rucaparib treatment. Genomic scarring can be assessed by quantifying the extent of loss of heterozygosity across the tumor genome (tumor genomic LOH). One of the main advantages of detecting tumor genomic LOH is that it can identify HRD tumors regardless of the underlying mechanisms, which include both known (i.e., BRCA mutations) and unknown genetic and other mechanisms.
Once determined, this signature will be prospectively applied to ARIEL2 PART 2 and ARIEL3. This Phase 2 study (ARIEL2) will also compare archival versus recently collected tumor tissue in order to validate the use of archival tumor tissue for assessment of HRD status in ARIEL3.
This study will include 2 parts:
PART 1 (completed enrollment): Evaluation of HRD status and rucaparib efficacy in patients who received ≥1 prior platinum-based regimen and had platinum-sensitive disease
PART 2 (completed enrollment): Evaluation of HRD status and rucaparib efficacy in patients who received at least 3 prior chemotherapy regimens
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Keywords
ovarian cancer, fallopian tube cancer, primary peritoneal cancer, peritoneal cancer, platinum sensitive, relapsed disease, PARP Inhibitor, rucaparib, homologous recombination, homologous recombination deficiency, genomic scarring, loss of heterozygosity, 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, ARIEL2, ARIEL 2, ARIEL3, ARIEL 3
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
491 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ovarian cancer
Arm Type
Experimental
Arm Description
rucaparib
Intervention Type
Drug
Intervention Name(s)
Oral rucaparib
Other Intervention Name(s)
CO-338, PF 01367338, AG 14699
Intervention Description
600 mg BID
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study)
Description
The primary efficacy endpoint of PFS is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST (Response Evaluation Criteria in Solid Tumors), as determined by the investigator or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
Time Frame
Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.
Title
Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study)
Description
The confirmed response rate by RECIST v1.1 is defined as the percentage of patients with a confirmed complete response (CR) or partial response (PR) on subsequent tumor assessment at least 28 days after first response documentation. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Time Frame
Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) by RECIST v1.1 (Part 1 of Study)
Description
The confirmed response rate by RECIST v1.1 is defined as the percentage of patients with a confirmed CR or PR on subsequent tumor assessment at least 28 days after first response documentation. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Time Frame
Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.
Title
Objective Response Rate (ORR) by RECIST v1.1 and GCIG CA-125 Criteria
Description
The endpoint of ORR defined as the percentage of patients with a best response of CR or PR using RECIST v 1.1 or a response per Gynecologic Cancer InterGroup cancer antigen 125 (GCIG CA-125) criteria. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter. A response to CA-125 has occurred if there is at least a 50% decrease from baseline: 1. in a sample collected after initiation of study treatment AND 2. that is confirmed in a subsequent sample collected ≥21 days after the prior sample. The absolute value of this confirmatory sample must be ≤110% of the prior sample. The date when the first sample with a 50% decrease from baseline is observed is the date of the CA-125 response.
Time Frame
Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.
Title
Duration of Response Per RECIST v1.1
Description
Duration of response (DOR) for any confirmed RECIST CR or PR measured from the date of the first occurrence of a response until the first occurrence of progressive disease (PD) per RECIST. For patients who continued treatment post-progression, the first date of progression was used for the analysis. Any patients with an ongoing response were censored at the date of the last post-baseline scan. Complete response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.
Time Frame
Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.
Title
Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study)
Description
Progression-Free Survival (PFS) is calculated as 1+ the number of days from the first dose of study drug to disease progression by RECIST, as determined by the investigator or death due to any cause, whichever occurs first. Progression is defined using RECIST v1.1, as at least a 20% increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.
Time Frame
Assessments every 8 weeks from C1D1 until disease progression, death or withdrawal of consent. After 18 months on study, assessments every 16 weeks. Total follow-up was up to approximately 3 years.
Title
Overall Survival (Part 2 of Study)
Description
Overall survival (OS) is defined as the number of days from the date of first dose of study drug to the date of death (due to any cause). Patients without a known date of death will be censored on the date the patient was last known to be alive.
Time Frame
All patients in Part 2 were followed for survival, subsequent therapy, and secondary malignancy every 12 weeks until death, loss to follow-up, withdrawal of consent from study or study closure, whichever happened first, up to 7 years.
Title
Steady State Trough (Cmin) Level Rucaparib Concentrations
Description
Per protocol, the secondary PK endpoint, trough (Cmin) concentrations of rucaparib were summarized with descriptive statistics overall and by cycle in all patients with at least one PK sample collected. Blood samples for trough level PK analysis of rucaparib were drawn at the following timepoints only: on Day 15 of Cycle 1 and on Day 1 of Cycles 2, 3, and 4. Data for other timepoints is not available.
Time Frame
Cycle 1 Day 15 to Cycle 4 Day 1, or approximately 10 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The following eligibility criteria pertain to patients enrolling into PART 2 of the study:
Inclusion:
Have a histologically confirmed diagnosis of high grade serous or Grade 2 or Grade 3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer
Received at least 3 prior chemotherapy regimens. Non-chemotherapy regimens and maintenance therapies administered as single agent treatment will not count as a chemotherapy regimen
Relapsed/progressive disease as confirmed by CT scan
Have biopsiable and measurable disease. Note: biopsy is optional for patients known to harbor a deleterious gBRCA mutation
Have sufficient archival formalin-fixed paraffin-embedded (FFPE) tumor tissue available for planned analyses
Exclusion:
History of prior cancers except for those that have been curatively treated, with no evidence of cancer currently (provided all chemotherapy was completed >6 months prior and/or bone marrow transplant >2 years prior to first dose of rucaparib).
Prior treatment with any PARP inhibitor
Symptomatic and/or untreated central nervous system metastases
Pre-existing duodenal stent and/or any other gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib
Hospitalization for bowel obstruction within 3 months prior to enrollment
Facility Information:
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Saint Jude Heritage Medical Center
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
UC San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of California, San Francisco
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
93401
Country
United States
Facility Name
Central Coast Medical Oncology
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Altus Research
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
University of Miami Hospital & Clinics Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
UF Health Cancer Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Horizon BioAdvance
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Johns Hopkins Kimmel Cancer Center
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
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Women's Cancer Care Associates
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
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 - A Woman's Cancer Institute
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28006
Country
United States
Facility Name
University of Cincinnati Physicians Company
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
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 Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73019
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
UPMC Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington - Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Royal North Shore Hospital
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Prince of Wales Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Royal Brisbane & Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Flinders Cancer Clinic - Flinders Medical Centre (FMC)
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Mercy Hospital for Women
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Crown Princess Mary Cancer Centre (Westmead Hospital)
City
Westmead
State/Province
Wentworthville
ZIP/Postal Code
NSW 2145
Country
Australia
Facility Name
Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N4N2
Country
Canada
Facility Name
Cross Cancer Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
BC Cancer Agency - Fraser Valley Centre
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
Vancouver Cancer Centre, British Columbia Cancer Agency (BCCA)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z4E6
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
Centre Hospitalier de L'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CHU de Québec - Université Laval
City
Québec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Institut Bergonie
City
Bordeaux
State/Province
Aquitaine
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Tenon
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75020
Country
France
Facility Name
Hôpital Européen Georges-Pompidou
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75908
Country
France
Facility Name
Institut de cancerologie Gustave Roussy
City
Villejuif
State/Province
Ile-de-France
ZIP/Postal Code
94805
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
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
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Instituto Valencia de Oncologia
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
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G120YN
Country
United Kingdom
Facility Name
Royal Marsden Sutton Hospital
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
Addenbrooke's Hospital
City
Cambridge
ZIP/Postal Code
CB20QQ
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust - Hammersmith Hospital
City
London
ZIP/Postal Code
W120HS
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
33941784
Citation
Swisher EM, Kwan TT, Oza AM, Tinker AV, Ray-Coquard I, Oaknin A, Coleman RL, Aghajanian C, Konecny GE, O'Malley DM, Leary A, Provencher D, Welch S, Chen LM, Wahner Hendrickson AE, Ma L, Ghatage P, Kristeleit RS, Dorigo O, Musafer A, Kaufmann SH, Elvin JA, Lin DI, Chambers SK, Dominy E, Vo LT, Goble S, Maloney L, Giordano H, Harding T, Dobrovic A, Scott CL, Lin KK, McNeish IA. Molecular and clinical determinants of response and resistance to rucaparib for recurrent ovarian cancer treatment in ARIEL2 (Parts 1 and 2). Nat Commun. 2021 May 3;12(1):2487. doi: 10.1038/s41467-021-22582-6.
Results Reference
derived
PubMed Identifier
31685558
Citation
Kristeleit RS, Oaknin A, Ray-Coquard I, Leary A, Balmana J, Drew Y, Oza AM, Shapira-Frommer R, Domchek SM, Cameron T, Maloney L, Goble S, Lorusso D, Ledermann JA, McNeish IA. Antitumor activity of the poly(ADP-ribose) polymerase inhibitor rucaparib as monotherapy in patients with platinum-sensitive, relapsed, BRCA-mutated, high-grade ovarian cancer, and an update on safety. Int J Gynecol Cancer. 2019 Nov;29(9):1396-1404. doi: 10.1136/ijgc-2019-000623.
Results Reference
derived
PubMed Identifier
27908594
Citation
Swisher EM, Lin KK, Oza AM, Scott CL, Giordano H, Sun J, Konecny GE, Coleman RL, Tinker AV, O'Malley DM, Kristeleit RS, Ma L, Bell-McGuinn KM, Brenton JD, Cragun JM, Oaknin A, Ray-Coquard I, Harrell MI, Mann E, Kaufmann SH, Floquet A, Leary A, Harding TC, Goble S, Maloney L, Isaacson J, Allen AR, Rolfe L, Yelensky R, Raponi M, McNeish IA. Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol. 2017 Jan;18(1):75-87. doi: 10.1016/S1470-2045(16)30559-9. Epub 2016 Nov 29.
Results Reference
derived
Links:
URL
http://arielstudy.com/
Description
ARIEL trials website
Learn more about this trial
A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
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