History of Changes for Study: NCT01968213

A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer (ARIEL3)

Latest version (submitted June 7, 2023) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	October 18, 2013	None (earliest Version on record)
2	October 24, 2013	Contacts/Locations and Study Status
3	December 9, 2013	Contacts/Locations and Study Status
4	January 7, 2014	Recruitment Status, Study Status and Contacts/Locations
5	March 12, 2014	Contacts/Locations and Study Status
6	April 7, 2014	Contacts/Locations, Study Status and Oversight
7	May 16, 2014	Contacts/Locations and Study Status
8	June 9, 2014	Contacts/Locations and Study Status
9	July 3, 2014	Contacts/Locations and Study Status
10	August 4, 2014	Contacts/Locations and Study Status
11	August 12, 2014	Contacts/Locations and Study Status
12	September 4, 2014	Contacts/Locations and Study Status
13	October 6, 2014	Contacts/Locations and Study Status
14	November 3, 2014	Contacts/Locations and Study Status
15	December 5, 2014	Contacts/Locations and Study Status
16	January 6, 2015	Contacts/Locations and Study Status
17	February 2, 2015	Contacts/Locations and Study Status
18	February 20, 2015	Contacts/Locations and Study Status
19	March 6, 2015	Outcome Measures, Study Description, Study Status and Eligibility
20	March 23, 2015	Contacts/Locations and Study Status
21	July 2, 2015	Study Status and Contacts/Locations
22	July 30, 2015	Contacts/Locations and Study Status
23	August 19, 2015	Contacts/Locations and Study Status
24	November 4, 2015	Contacts/Locations and Study Status
25	December 18, 2015	Contacts/Locations and Study Status
26	January 14, 2016	Contacts/Locations and Study Status
27	March 10, 2016	Study Status and Contacts/Locations
28	April 28, 2016	Recruitment Status, Contacts/Locations and Study Status
29	July 5, 2016	Recruitment Status and Study Status
30	May 17, 2017	Study Status, Contacts/Locations and Sponsor/Collaborators
	Results Submission Events
May 8, 2018		Returned after QC review: June 7, 2018
31	August 1, 2018	Contacts/Locations, Study Status, Outcome Measures, Study Design, Document Section, Results and Eligibility
32	November 27, 2018	Study Status and Outcome Measures
33	March 26, 2019	Contacts/Locations and Study Status
34	May 30, 2019	Study Status and Outcome Measures
35	July 30, 2019	Study Status
36	February 11, 2020	Study Status
37	May 4, 2021	Study Status and Outcome Measures
38	June 8, 2022	Study Status
39	February 8, 2023	Recruitment Status, Adverse Events, Outcome Measures, More Information, Study Status, Document Section, Participant Flow, Study Identification, Baseline Characteristics and Arms and Interventions
40	June 7, 2023	Study Identification, Sponsor/Collaborators and Study Status

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Study NCT01968213
Submitted Date: October 18, 2013 (v1)

Study Identification


Unique Protocol ID:	CO-338-014
Brief Title:	A Study of Rucaparib as Switch Maintenance Following Platinum-Based Chemotherapy in Patients With Platinum-Sensitive, High-Grade Serous or Endometrioid Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer (ARIEL3)
Official Title:	Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous and Endometrioid Ovarian Cancer (ARIEL3)
Secondary IDs:

Study Status


Record Verification:	October 2013
Overall Status:	Not yet recruiting
Study Start:	January 2014
Primary Completion:	January 2016 [Anticipated]
Study Completion:	November 2016 [Anticipated]

First Submitted:	October 17, 2013
First Submitted that Met QC Criteria:	October 18, 2013
First Posted:	October 23, 2013 [Estimate]

Last Update Submitted that Met QC Criteria:	October 18, 2013
Last Update Posted:	October 23, 2013 [Estimate]

Study Description

Brief Summary:

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). Clinical data have shown that ovarian cancer patients with and without evidence of a gBRCA mutation benefit from treatment with a PARP and that maintenance treatment with a PARP inhibitor following a response to platinum-based treatment increases PFS in patients with ovarian cancer. While patients with a BRCA mutation derived the most benefit, patients without evidence of a BRCA mutation also derived significant benefit.

Patients enrolled into this study will be stratified into 3 groups based on gene mutations identified in their tumor tissue. The purpose of this study is to identify which of these groups of patients will most likely benefit from treatment with rucaparib. It is anticipated that rucaparib will provide therapeutic benefit and increase PFS in patients with HRD associated with a BRCA gene mutation or other HR gene alteration.

Conditions


Conditions:	Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer
Keywords:	ARIEL3 ARIEL 3 platinum sensitive PARP Inhibitor rucaparib homologous recombination homologous recombination deficiency 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

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	540 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Rucaparib Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.	Drug: Rucaparib Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole. Other Names: CO-338; PF 01367338, AG 14699
Placebo Comparator: Placebo Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.	Drug: Placebo Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.

Outcome Measures


Primary Outcome Measures:
1.	Disease progression according to RECIST Version 1.1 (v1.1), as assessed by the investigator, or death from any cause (investigator Progression Free Survival or invPFS), in molecularly defined subgroups [ Time Frame: Screening, within 7 days prior to the end of every 3rd cycle of treament, and Treatment Discontinuation visit. Study data collection expected to last for ~3 years. ]
Secondary Outcome Measures:
1.	Disease progression according to RECIST v1.1, as assessed by Independent Radiology Review (IRR), or death from any cause (irrPFS), in molecularly defined subgroups [ Time Frame: Screening, within 7 days prior to the end of every 3rd cycle of treament, and Treatment Discontinuation visit. Study data collection expected to last for ~3 years. ]
2.	Time to a specified decrease in the DSR P subscale of the FOSI-18 patient reported outcome questionnaire [ Time Frame: Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Study data collection expected to last for ~3 years. ]
3.	Time to a specified decrease in the total score of the FOSI-18 patient reported outcome questionnaire [ Time Frame: Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Study data collection expected to last for ~3 years. ]
4.	Overall Survival (OS) [ Time Frame: Continuously for ~5 years after patient enrolls into study. ]
5.	Incidence of Adverse Events (AEs), clinical laboratory abnormalities, and dose modifications [ Time Frame: Continuously for ~3 years after patient enrolls into study. ]
6.	Individual model parameter estimates of rucaparib and covariates identification (PK) [ Time Frame: Cycle 1 Day 15, and Cycle 2 Day 1, Cycle 2 Day 15, Cycle 4 Day 1, and Cycle 7 Day 1. Study data collection expected to last for ~7 months. ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	Female
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer. Received ≥2 prior platinum-based treatment regimens. Received no more than 1 non-platinum regimen. Must have had at least a 6-month disease-free period following prior treatment with platinum-based chemotherapy and achieved a response. Have sufficient archival tumor tissue for analysis. Exclusion Criteria: History of prior cancer except for non-melanoma skin cancer, curatively treated solid tumor (>5 years ago without evidence of recurrence), and synchronous endometrial cancer (Stage 1A) with ovarian cancer. Prior treatment with any PARP inhibitor, including rucaparib. Patients who received prior iniparib are eligible. Untreated or symptomatic central nervous system metastases. Prior gastrectomy or upper bowel removal or any gastrointestinal disorder that would interfere with the absorption of rucaparib. Required drainage of ascites fluid during end of chemotherapy treatment or after completion of chemotherapy treatment.

Contacts/Locations


Central Contact Person:	Clovis Oncology Clinical Trial Information Email: clinicaltrialinfo@clovisoncology.com
Study Officials:	Heidi Giordano Study Director Clovis Oncology, Inc.
Locations:

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