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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01891344




Registration number
NCT01891344
Ethics application status
Date submitted
20/06/2013
Date registered
3/07/2013
Date last updated
12/06/2023

Titles & IDs
Public title
A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)
Scientific 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)
Secondary ID [1] 0 0
2013-000517-20
Secondary ID [2] 0 0
CO-338-017
Universal Trial Number (UTN)
Trial acronym
ARIEL2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Epithelial Ovarian Cancer 0 0
Fallopian Tube Cancer 0 0
Peritoneal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Stomach
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oral rucaparib

Experimental: Ovarian cancer - rucaparib


Treatment: Drugs: Oral rucaparib
600 mg BID
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD (Homologous Recombination Deficiency) Subgroups (Part 1 of Study)
Timepoint [1] 0 0
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 outcome [2] 0 0
Objective Response Rate (ORR) by RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study)
Timepoint [2] 0 0
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 outcome [1] 0 0
Objective Response Rate (ORR) by RECIST v1.1 (Part 1 of Study)
Timepoint [1] 0 0
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 outcome [2] 0 0
Objective Response Rate (ORR) by RECIST v1.1 and GCIG CA-125 Criteria
Timepoint [2] 0 0
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 outcome [3] 0 0
Duration of Response Per RECIST v1.1
Timepoint [3] 0 0
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 outcome [4] 0 0
Progression-free Survival (PFS) According to RECIST v1.1 in Molecularly-defined HRD Subgroups (Part 2 of Study)
Timepoint [4] 0 0
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 outcome [5] 0 0
Overall Survival (Part 2 of Study)
Timepoint [5] 0 0
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 outcome [6] 0 0
Steady State Trough (Cmin) Level Rucaparib Concentrations
Timepoint [6] 0 0
Cycle 1 Day 15 to Cycle 4 Day 1, or approximately 10 weeks

Eligibility
Key inclusion criteria
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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/09/2021
Sample size
Target
Accrual to date
Final
491
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WentworthvilleWA
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [3] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [4] 0 0
Flinders Cancer Clinic - Flinders Medical Centre (FMC) - Bedford Park
Recruitment hospital [5] 0 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [6] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [7] 0 0
Crown Princess Mary Cancer Centre (Westmead Hospital) - Westmead
Recruitment hospital [8] 0 0
Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
2031 - Sydney
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment postcode(s) [7] 0 0
NSW 2145 - Westmead
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alaska
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Colorado
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Florida
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United States of America
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Indiana
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United States of America
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Kentucky
Country [8] 0 0
United States of America
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Maryland
Country [9] 0 0
United States of America
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Massachusetts
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Minnesota
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Missouri
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Nevada
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New York
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North Carolina
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United States of America
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Ohio
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Washington
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Canada
State/province [20] 0 0
Alberta
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Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
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Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Canada
State/province [24] 0 0
Québec
Country [25] 0 0
France
State/province [25] 0 0
Aquitaine
Country [26] 0 0
France
State/province [26] 0 0
Ile-de-France
Country [27] 0 0
France
State/province [27] 0 0
Midi-Pyrenees
Country [28] 0 0
France
State/province [28] 0 0
Pays De La Loire
Country [29] 0 0
France
State/province [29] 0 0
Rhone-Alpes
Country [30] 0 0
Spain
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Barcelona
Country [31] 0 0
Spain
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Valencia
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United Kingdom
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Scotland
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United Kingdom
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Surrey
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United Kingdom
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West Yorkshire
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United Kingdom
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Cambridge
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
State/province [38] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
pharmaand GmbH
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Foundation Medicine
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Myriad Genetics, Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01891344
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries