Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3) (ARIEL3)
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| ClinicalTrials.gov Identifier: NCT01968213 |
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Recruitment Status :
Completed
First Posted : October 23, 2013
Results First Posted : August 3, 2018
Last Update Posted : June 9, 2023
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Sponsor:
pharmaand GmbH
Collaborators:
Foundation Medicine
Myriad Genetics, Inc.
Information provided by (Responsible Party):
pharmaand GmbH
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Conditions |
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer |
| Interventions |
Drug: Rucaparib Drug: Placebo |
| Enrollment | 564 |
Participant Flow
| Recruitment Details | 564 subjects were recruited from 87 sites across 11 countries and randomized (2:1) to treatment with rucaparib or placebo |
| Pre-assignment Details |
| Arm/Group Title | Rucaparib 600 mg Tablets | Placebo Tablets |
|---|---|---|
 Arm/Group Description |
Taken orally twice daily (continuous 28 day treatment cycles) | Taken orally twice daily (continuous 28 day treatment cycles) |
| Period Title: Overall Study | ||
| Started | 375 | 189 |
| Completed | 375 | 189 |
| Not Completed | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Rucaparib 600 mg Tablets | Placebo Tablets | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Taken orally twice daily (continuous 28 day treatment cycles) | Taken orally twice daily (continuous 28 day treatment cycles) | Total of all reporting groups | |
| Overall Number of Baseline Participants | 375 | 189 | 564 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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| Number Analyzed | 375 participants | 189 participants | 564 participants | |
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61
(39 to 84)
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62
(36 to 85)
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61
(36 to 85)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 375 participants | 189 participants | 564 participants | |
| Female |
375 100.0%
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189 100.0%
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564 100.0%
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| Male |
0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 375 participants | 189 participants | 564 participants | |
| American Indian or Alaska Native |
3 0.8%
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1 0.5%
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4 0.7%
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| Asian |
14 3.7%
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7 3.7%
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21 3.7%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
6 1.6%
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2 1.1%
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8 1.4%
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| White |
292 77.9%
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144 76.2%
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436 77.3%
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| More than one race |
12 3.2%
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8 4.2%
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20 3.5%
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| Unknown or Not Reported |
48 12.8%
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27 14.3%
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75 13.3%
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Best Response from Previous Platinum Therapy
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 375 participants | 189 participants | 564 participants | |
| RECIST CR |
126 33.6%
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64 33.9%
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190 33.7%
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| RECIST / CA-125 PR |
249 66.4%
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125 66.1%
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374 66.3%
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[1]
Measure Description: Complete and partial responses at baseline must have been reported according to RECIST v1.1, as assessed by CT/MRI, and GCIG CA-125 response criteria, and defined as: Complete Response (CR) i.e. absence of any detectable disease and CA-125<ULN; Partial Response (PR), ≥30% decrease in the sum of the longest diameter of measurable lesions or if non-measurable disease at baseline, a GCIG CA-125 response (least a 50% reduction in CA-125 levels from a pretreatment sample (which must have initially been 2xULN) and confirmed after ≥21 days). CA-125 must have been <ULN for all PRs.
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Penultimate Progression-free (PF) Interval
[1] Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 375 participants | 189 participants | 564 participants | |
| 6-12 Months |
151 40.3%
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76 40.2%
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227 40.2%
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| >12 Months |
224 59.7%
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113 59.8%
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337 59.8%
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[1]
Measure Description: 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).
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Bulky Lesions (lesion >20 mm) at Baseline
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 375 participants | 189 participants | 564 participants | |
| Yes |
71 18.9%
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29 15.3%
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100 17.7%
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| No |
304 81.1%
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160 84.7%
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464 82.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor's agreements with investigators require proposed public disclosures of trial results to be submitted to Sponsor for review prior to publication. Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.
Results Point of Contact
| Name/Title: | Medical Information Department |
| Organization: | Clovis Oncology, Inc. |
| Phone: | +1 415 409 7220 |
| EMail: | medinfo@clovisoncology.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | pharmaand GmbH |
| ClinicalTrials.gov Identifier: | NCT01968213 |
| Other Study ID Numbers: |
CO-338-014 2013-000518-39 ( EudraCT Number ) |
| First Submitted: | October 17, 2013 |
| First Posted: | October 23, 2013 |
| Results First Submitted: | May 8, 2018 |
| Results First Posted: | August 3, 2018 |
| Last Update Posted: | June 9, 2023 |