A Study of Rucaparib in Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARIEL2)



Status:Active, not recruiting
Conditions:Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:18 - Any
Updated:5/17/2018
Start Date:September 2013

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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)

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.

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). The safety and efficacy of
rucaparib has been evaluated in several Phase 1 and Phase 2 studies. An oral formulation is
the focus of current development efforts. Rucaparib is currently being investigated as
monotherapy in patients with cancer associated with breast cancer susceptibility gene 1
(BRCA1) or BRCA2 mutations.

Clinical data with PARP inhibitors indicate there is an ovarian cancer patient population
beyond just those with germline BRCA (gBRCA) mutations that may benefit from treatment with a
PARP inhibitor. This study will define a molecular signature of HRD in ovarian cancer that
correlates with response to rucaparib and enables selection of appropriate ovarian cancer
patients for treatment with rucaparib. The HRD signature will be based on an association
between the extent of genomic scarring (a downstream consequence of HRD) in a patient's tumor
and observed clinical benefit from rucaparib treatment. Genomic scarring can be assessed by
quantifying the extent of loss of heterozygosity across the tumor genome (tumor genomic LOH).
One of the main advantages of detecting tumor genomic LOH is that it can identify HRD tumors
regardless of the underlying mechanisms, which include both known (i.e., BRCA mutations) and
unknown genetic and other mechanisms.

Once determined, this signature will be prospectively applied to ARIEL2 PART 2 and ARIEL3.
This Phase 2 study (ARIEL2) will also compare archival versus recently collected tumor tissue
in order to validate the use of archival tumor tissue for assessment of HRD status in ARIEL3.

This study will include 2 parts:

PART 1 (completed enrollment): Evaluation of HRD status and rucaparib efficacy in patients
who received ≥1 prior platinum-based regimen and had platinum-sensitive disease

PART 2 (currently enrolling): Evaluation of HRD status and rucaparib efficacy in patients who
received at least 3 prior chemotherapy regimens

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

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
We found this trial at
38
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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4671 S. Congress Ave.
Lake Worth, Florida 33461
561-641-0404
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Albany, New York 12208
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Anchorage, Alaska 99508
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Baltimore, Maryland 21287
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Fullerton, California 92835
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Jacksonville, Florida 32216
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Lafayette, Indiana 47905
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Lakewood, Colorado 80228
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Louisville, Kentucky 40207
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550 1st Ave
New York, New York 10016
(212) 263-7300
New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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Orlando, Florida 32804
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Orlando, Florida 32804
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Orlando, Florida 32806
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Palo Alto, California 94304
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Philadelphia, Pennsylvania 19111
Phone: 888-309-2427
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Pittsburgh, Pennsylvania 15232
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Rochester, Minnesota 55905
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Saint Leonards, New South Wales 2065
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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San Diego, California 92093
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45 Castro Street
San Francisco, California 94114
(415) 600-6000
California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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San Francisco, California 94143
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San Luis Obispo, California 93401
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Santa Maria, California 93454
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Tucson, Arizona 85724
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