A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
NCT ID: NCT01891344
Last Updated: 2023-06-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
491 participants
INTERVENTIONAL
2013-10-30
2021-09-28
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ovarian cancer
rucaparib
Oral rucaparib
600 mg BID
Interventions
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Oral rucaparib
600 mg BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Foundation Medicine
INDUSTRY
Myriad Genetics, Inc.
INDUSTRY
pharmaand GmbH
INDUSTRY
Responsible Party
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Locations
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Providence Alaska Medical Center
Anchorage, Alaska, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
Saint Jude Heritage Medical Center
Fullerton, California, United States
University of California Los Angeles
Los Angeles, California, United States
UC San Diego
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, United States
Central Coast Medical Oncology
Santa Maria, California, United States
Stanford University
Stanford, California, United States
Rocky Mountain Cancer Centers
Lakewood, Colorado, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Altus Research
Lake Worth, Florida, United States
University of Miami Hospital & Clinics Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Florida Hospital Cancer Institute
Orlando, Florida, United States
UF Health Cancer Center
Orlando, Florida, United States
Horizon BioAdvance
Lafayette, Indiana, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Johns Hopkins Kimmel Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States
Women's Cancer Care Associates
Albany, New York, United States
New York University Langone Medical Center
New York, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Hope - A Woman's Cancer Institute
Asheville, North Carolina, United States
University of Cincinnati Physicians Company
Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
UPMC Cancer Center
Pittsburgh, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, United States
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Prince of Wales Hospital
Sydney, New South Wales, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia
Flinders Cancer Clinic - Flinders Medical Centre (FMC)
Bedford Park, South Australia, Australia
Mercy Hospital for Women
Heidelberg, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Crown Princess Mary Cancer Centre (Westmead Hospital)
Westmead, Wentworthville, Australia
Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Centre
Edmonton, Alberta, Canada
British Columbia Cancer Agency
Kelowna, British Columbia, Canada
BC Cancer Agency - Fraser Valley Centre
Surrey, British Columbia, Canada
Vancouver Cancer Centre, British Columbia Cancer Agency (BCCA)
Vancouver, British Columbia, Canada
London Regional Cancer Centre
London, Ontario, Canada
Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Centre Hospitalier de L'Universite de Montreal
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
CHU de Québec - Université Laval
Québec, , Canada
Institut Bergonie
Bordeaux, Aquitaine, France
Centre Leon Berard
Lyon, Auvergne-Rhône-Alpes, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Institut Claudius Regaud
Toulouse, Midi-Pyrenees, France
Centre Catherine de Sienne
Nantes, Pays de la Loire Region, France
Hopital Tenon
Paris, Île-de-France Region, France
Hôpital Européen Georges-Pompidou
Paris, Île-de-France Region, France
Institut de cancerologie Gustave Roussy
Villejuif, Île-de-France Region, France
Hospital Vall d'Hebron
Barcelona, , Spain
Instituto Valencia de Oncologia
Valencia, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom
Royal Marsden Sutton Hospital
Sutton, Surrey, United Kingdom
St James University Hospital
Leeds, West Yorkshire, United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Royal Marsden NHS Foundation Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust - Hammersmith Hospital
London, , United Kingdom
University College London
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Sir Bobby Robson Cancer Trials Research Centre, Northern Centre for Cancer Care
Newcastle upon Tyne, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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ARIEL trials website
Other Identifiers
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2013-000517-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CO-338-017
Identifier Type: -
Identifier Source: org_study_id
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