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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Study Status Terminated
Application Number /
Requirement Number
P200006 / PAS001
Date Original Protocol Accepted 02/03/2022
Date Current Protocol Accepted 10/28/2022
Study Name ARIEL2 PAS
Device Name FoundationOne Liquid CDx (F1 Liquid CDx)
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Objectives Samples from ARIEL2 (CO-338-017) will be used to support the clinical utility of the F1L CDx assay for selecting ovarian cancer
patients with a deleterious BRCA1 or BRCA2 mutation who may benefit from rucaparib treatment. ARIEL2 was a two-part open-label Phase 2 study intended to determine the safety and efficacy of rucaparib in patients with relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer. Part 1 enrolled patients who received greater than or equal to 1 prior platinum-based regimen and had platinumsensitive disease. Patients in Part 2 must have received 3 to 4 prior chemotherapy regimens and had a documented treatment-free interval of greater than or equal to 6 months following their first chemotherapy regimen. Patients received continuous dosing with oral rucaparib at 600 mg twice daily (BID) in 4-week cycles.
Patients enrolled in ARIEL2 were not biomarker selected, although Part 1 was capped at a maximum of 15 patients with prior known gBRCA mutation. A tumor tissue biopsy sample was required to be collected during screening from all patients except for Part 2 patients known to harbor a deleterious
gBRCA mutation (for these patients the screening biopsy sample was optional and an archival FFPE tumor tissue sample was mandatory). Tumor samples were retrospectively analyzed for BRCA mutation status by FMI. Up to 9 mL of whole blood was collected for ctDNA analysis was collected at screening or just prior to rucaparib treatment (e.g. Day 1 of Cycle 1). These samples will be used to support the clinical utility of the F1L CDx.
Study Population Enrollment in ARIEL2 study is complete, and a total of 491 patients (204 patients in Part 1 and 287 in Part 2) were enrolled and treated with at least one dose of rucaparib, including both BRCA positive and BRCA negative patients, and all patients had a known BRCA result from tissue testing using
the CTA or local BRCA testing results prior to enrollment. Of the 491 patients, screening plasma with sufficient volume was available for 271 patients, among which, 217 were successfully sequenced using the F1L CDx assay. The proposed analysis population in this protocol (with a sample size of 60) is a subset of these 217 patients. See below for details of the proposed analysis population for this study.
Analysis Population
Expanded F1L CDx Positive Primary Efficacy Population (PEP) consists of patients (n=60) with ovarian cancer and a BRCA mutation detected by F1L CDx and treated with 600 mg BID rucaparib with 2 or more prior chemotherapy regimens from study ARIEL2. The expanded F1L CDx Positive PEP can be divided into the following two sub-populations:
Original NDA PEP sub-population (n=26): patients who were part of the original NDA (209115) population and F1L CDx positive
Post NDA PEP sub-population (n=34): patients who were enrolled in the ARIEL2 study after the cutpoint for inclusion in original NDA 209115 and who also fit the clinical characteristics of the Original NDA PEP sub-population. They were additionally included in the Expanded F1L CDx Positive PEP as they represent an expanded population to determine clinical outcome using F1L CDx selection.
All demographics and efficacy analyses outlined in this SAP will be performed for the three populations separately: original NDA PEP sub-population (n=26), post NDA PEP sub-population (n=34) and the entire expanded F1L CDx positive PEP (n=60)
Sample Size Sixty patients with F1L CDx positive status that received 2 or more prior chemotherapy regimens prior to enrollment in ARIEL 2.
Key Study Endpoints Primary Endpoint:
Investigator-assessed Objective Response Rate (ORR)
The primary efficacy endpoint is Objective Response Rate (ORR) by RECIST v1.1 as assessed by the investigator.
Secondary Endpoints:
ORR by Platinum Sensitivity and Number or Prior Chemotherapies
Since platinum sensitivity status (i.e., sensitivity, resistant, and refractory) and number of prior number of chemotherapies (2,
>=3) are known predictors of response, the ORR rates may be further broken down by platinum status and number of prior
Duration of Response (DOR)
Duration of response (DOR) for any confirmed RECIST CR or PR will be measured from the date of the first occurrence of a
response until the first occurrence of PD per RECIST.
Follow-up Visits and Length of Follow-up Patients were required to have measurable disease at baseline. Efficacy was assessed by tumor response at the end of every 8
weeks (± 4 days), and posttreatment (if patient discontinued treatment for any reason other than radiologically confirmed
disease progression) until radiologically confirmed disease progression, death or initiation of subsequent treatment) using
the Response Evaluation Criteria in Solid Tumors (RECIST)1 Version 1.1.
After discontinuing protocol treatment, patients were to attend the safety follow-up visit 28 (± 3) days after the last
dose of rucaparib. All patients who discontinued treatment for any reason other than radiologically confirmed disease
progression were to continue to have scans every 8 weeks (± 4 days) until radiologically confirmed disease progression, death,
or initiation of subsequent treatment. Patients who had been on study at least 18 months could decrease the frequency of
disease assessments to every 16 (± 2) weeks.

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Food and Drug Administration
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Email: MandatedStudiesPrograms@fda.hhs.gov

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