Ovarian Cancer Clinical Trial
Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or 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.
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.
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.
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There are 95 Locations for this study
Tucson Arizona, 85704, United States
Fullerton California, 92835, United States
Sacramento California, 95817, United States
San Francisco California, 94158, United States
San Luis Obispo California, 93422, United States
Santa Maria California, 93454, United States
Santa Monica California, 90404, United States
Lakewood Colorado, 80228, United States
Hollywood Florida, 33021, United States
Miami Florida, 33136, United States
Orlando Florida, 32804, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Saint Louis Missouri, 63110, United States
New York New York, 10065, United States
Asheville North Carolina, 28806, United States
Columbus Ohio, 43210, United States
Philadelphia Pennsylvania, 19104, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Sydney New South Wales, 2031, Australia
Westmead New South Wales, 2145, Australia
Herston Queensland, 4029, Australia
Bedford Park South Australia, 5042, Australia
Parkville Victoria, 3052, Australia
Nedlands Western Australia, 6009, Australia
Subiaco Western Australia, 608, Australia
Antwerpen , 2610, Belgium
Gent , B-900, Belgium
Leuven , 3000, Belgium
Namur , 5000, Belgium
Calgary Alberta, T2N4N, Canada
Edmonton Alberta, T6G1Z, Canada
Hamilton Ontario, L8V5C, Canada
London Ontario, N6A4L, Canada
Ottawa Ontario, K1H8L, Canada
Toronto Ontario, M5G2M, Canada
Montreal Quebec, H2L4M, Canada
Quebec , G1R2J, Canada
Caen Cedex 05 Basse-Normandie, 14076, France
Villejuif Ile De France, 94805, France
Paris Ile-de-France, 75908, France
Toulouse Midi-Pyrenees, 31052, France
Nantes Cedex Pays De La Loire, 44202, France
Lyon Rhone-Alpes, 69373, France
Pierre Benite Rhone-Alpes, 69495, France
Bordeaux , 33076, France
Paris , 75020, France
Stuttgart Baden-Wuerttemberg, 70174, Germany
Ludwigsburg Baden-Wuerttembert, 71640, Germany
Munich Bavaria, 80637, Germany
Frankfurt am Main Hessen, 60596, Germany
Wiesbaden Hessen, 65199, Germany
Chemnitz Sachsen, 09116, Germany
Dresden Sachsen, 01307, Germany
Haifa , 31096, Israel
Haifa , , Israel
Petach-Tikva , 49100, Israel
Ramat Gan , 52621, Israel
Tel-Aviv , 64239, Israel
Zerifin , 70300, Israel
Faenza Ravenna, 48018, Italy
Reggio Emilia Reggio Nella Emilia, 42100, Italy
Bologna , 40138, Italy
Milan , 20133, Italy
Milan , 20141, Italy
Modena , 41124, Italy
Napoli , 80131, Italy
Roma , 00158, Italy
Auckland Grafton, 1023, New Zealand
Palmerston North Manawatu, 4442, New Zealand
Newtown Wellington, 6021, New Zealand
Oviedo Asturias, 33011, Spain
A Coruna , 15009, Spain
Barcelona , 8035, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Malaga , 29011, Spain
Sevilla , 41013, Spain
Valencia , 46009, Spain
Valencia , 46010, Spain
London England, SW3 6, United Kingdom
Belfast Northern Ireland, BT9 7, United Kingdom
Glasgow Scotland, G120Y, United Kingdom
Sutton Surrey, SM2 5, United Kingdom
Leeds West Yorkshire, LS97T, United Kingdom
Cambridge , CB20Q, United Kingdom
London , EC1M6, United Kingdom
London , W120H, United Kingdom
London , W1G6A, United Kingdom
London , W1T4T, United Kingdom
Manchester , M204B, United Kingdom
Newcastle Upon Tyne , NE77D, United Kingdom
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