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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
NA
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
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United States of America
State/province [2] 0 0
Arizona
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United States of America
State/province [3] 0 0
California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
State/province [6] 0 0
Indiana
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United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
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United States of America
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Massachusetts
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United States of America
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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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United States of America
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North Carolina
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United States of America
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Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
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United States of America
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Pennsylvania
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United States of America
State/province [18] 0 0
Texas
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United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
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
State/province [30] 0 0
Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Valencia
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Scotland
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Surrey
Country [34] 0 0
United Kingdom
State/province [34] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01891344