Ovarian Cancer Clinical Trial
— ARIEL2Official 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)
Verified date | June 2023 |
Source | zr Pharma & GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 491 |
Est. completion date | September 28, 2021 |
Est. primary completion date | November 5, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Flinders Cancer Clinic - Flinders Medical Centre (FMC) | Bedford Park | South Australia |
Australia | Mercy Hospital for Women | Heidelberg | Victoria |
Australia | Royal Brisbane & Women's Hospital | Herston | Queensland |
Australia | Charles Gairdner Hospital | Nedlands | Western Australia |
Australia | Royal Melbourne Hospital | Parkville | Victoria |
Australia | Royal North Shore Hospital | Saint Leonards | New South Wales |
Australia | Prince of Wales Hospital | Sydney | New South Wales |
Australia | Crown Princess Mary Cancer Centre (Westmead Hospital) | Westmead | Wentworthville |
Canada | Tom Baker Cancer Centre | Calgary | Alberta |
Canada | Cross Cancer Centre | Edmonton | Alberta |
Canada | British Columbia Cancer Agency | Kelowna | British Columbia |
Canada | London Regional Cancer Centre | London | Ontario |
Canada | Centre Hospitalier de L'Universite de Montreal | Montreal | Quebec |
Canada | Jewish General Hospital | Montreal | Quebec |
Canada | Ottawa Hospital Cancer Centre | Ottawa | Ontario |
Canada | CHU de Québec - Université Laval | Québec | |
Canada | BC Cancer Agency - Fraser Valley Centre | Surrey | British Columbia |
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
Canada | Vancouver Cancer Centre, British Columbia Cancer Agency (BCCA) | Vancouver | British Columbia |
France | Institut Bergonie | Bordeaux | Aquitaine |
France | Centre Leon Berard | Lyon | Rhone-Alpes |
France | Centre Catherine de Sienne | Nantes | Pays De La Loire |
France | Hôpital Européen Georges-Pompidou | Paris | Ile-de-France |
France | Hopital Tenon | Paris | Ile-de-France |
France | Centre Hospitalier Lyon Sud | Pierre-Benite | Rhone-Alpes |
France | Institut Claudius Regaud | Toulouse | Midi-Pyrenees |
France | Institut de cancerologie Gustave Roussy | Villejuif | Ile-de-France |
Spain | Hospital Vall d'Hebron | Barcelona | |
Spain | Hospital Clinico Universitario de Valencia | Valencia | |
Spain | Instituto Valencia de Oncologia | Valencia | |
United Kingdom | Addenbrooke's Hospital | Cambridge | |
United Kingdom | Beatson West of Scotland Cancer Centre | Glasgow | Scotland |
United Kingdom | St James University Hospital | Leeds | West Yorkshire |
United Kingdom | Imperial College Healthcare NHS Trust - Hammersmith Hospital | London | |
United Kingdom | Royal Marsden NHS Foundation Trust | 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 | Royal Marsden Sutton Hospital | Sutton | Surrey |
United States | Women's Cancer Care Associates | Albany | New York |
United States | Providence Alaska Medical Center | Anchorage | Alaska |
United States | Hope - A Woman's Cancer Institute | Asheville | North Carolina |
United States | Johns Hopkins Kimmel Cancer Center | Baltimore | Maryland |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of Cincinnati Physicians Company | Cincinnati | Ohio |
United States | The Ohio State University Wexner Medical Center | Columbus | Ohio |
United States | Saint Jude Heritage Medical Center | Fullerton | California |
United States | Comprehensive Cancer Centers of Nevada | Henderson | Nevada |
United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Mayo Clinic Jacksonville | Jacksonville | Florida |
United States | Horizon BioAdvance | Lafayette | Indiana |
United States | Altus Research | Lake Worth | Florida |
United States | Rocky Mountain Cancer Centers | Lakewood | Colorado |
United States | University of California Los Angeles | Los Angeles | California |
United States | Norton Cancer Institute | Louisville | Kentucky |
United States | University of Miami Hospital & Clinics Sylvester Comprehensive Cancer Center | Miami | Florida |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
United States | New York University Langone Medical Center | New York | New York |
United States | University of Oklahoma | Oklahoma City | Oklahoma |
United States | Florida Hospital Cancer Institute | Orlando | Florida |
United States | UF Health Cancer Center | Orlando | Florida |
United States | Fox Chase Cancer Center | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | UPMC Cancer Center | Pittsburgh | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Washington University School of Medicine | Saint Louis | Missouri |
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 | University of Washington - Seattle Cancer Care Alliance | Seattle | Washington |
United States | Stanford University | Stanford | California |
United States | University of Arizona Cancer Center | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
zr Pharma & GmbH | Foundation Medicine, Myriad Genetics, Inc. |
United States, Australia, Canada, France, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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. | |
Primary | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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 | 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. | 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. | |
Secondary | 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. | Cycle 1 Day 15 to Cycle 4 Day 1, or approximately 10 weeks |
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