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



Status:Active, not recruiting
Conditions:Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/30/2019
Start Date:January 2014
End Date:June 2020

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Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous and Endometrioid Ovarian Cancer (ARIEL3)

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 evaluate patient response
to maintenance treatment with rucaparib versus placebo. Response to treatment will be
analyzed based on homologous recombination (HR) status of tumor samples.

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 tumor HRD status.
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.

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 including platinum based regimen
that must have been administered immediately prior to maintenance therapy in this
trial.

- Received no more than 1 non-platinum chemotherapy regimen. Prior hormonal therapy will
not be counted as a non-platinum regimen.

- Must have had at least a 6-month disease-free period following prior treatment with
the penultimate platinum-based chemotherapy and achieved a response.

- For the last chemotherapy course prior to study entry, patients must have received a
platinum-based doublet chemotherapy regimen and have achieved a CR or PR (as defined
by RECIST) and/or a GCIG CA-125 response.

- Have sufficient archival tumor tissue for analysis.

Exclusion Criteria:

- History of prior cancer except for non-melanoma skin cancer, breast cancer curatively
> 3 years ago, 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.

- Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would,
in the opinion of the Investigator, interfere with absorption of study drug.

- Required drainage of ascites during the final 2 cycles of their last platinum-based
regimen and/or during the period between the last dose of chemotherapy of that regimen
and randomization to maintenance treatment in this study.
We found this trial at
23
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Asheville, North Carolina
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Baltimore, Maryland 21287
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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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Detroit, MI
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Fullerton, California 92835
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Hollywood, Florida
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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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Lakewood, Colorado 80228
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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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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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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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4501 X St
Sacramento, California 95817
(916) 734-5800
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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500 Parnassus Ave
San Francisco, California 94143
(415) 476-9000
University of California at San Francisco (UCSF) The leading university exclusively focused on health, UC...
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San Luis Obispo, California 93401
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Santa Maria, California 93454
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Santa Monica, California 90404
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Seattle, Washington 98195
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Sydney, New South Wales 2031
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Tucson, Arizona 85724
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