Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer
- Conditions
- Platinum-resistant Ovarian Cancer
- Interventions
- Registration Number
- NCT04729608
- Lead Sponsor
- Aravive, Inc.
- Brief Summary
This is a randomized, double-blind Phase 3 study to compare the efficacy and safety of batiraxcept (AVB-S6-500) in combination with paclitaxel (PAC) versus placebo in combination with PAC in patients with platinum resistant recurrent ovarian cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 366
- Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible.
- Aged 18 years or older
- Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1
- Platinum-resistant disease (defined as progression within ≤6 months from completion of most recent platinum-containing regimen and calculated from the date of the last administered dose of platinum therapy).Subject may have been treated with additional regimen(s) subsequent to determination of platinum resistance.
- Available archived tumor tissue or if archived tissue is not available, a fresh tumor biopsy.
- Received at least 1 but not more than 4 prior therapy regimens.
Note: Maintenance therapy OR hormonal therapies should not be counted as a separate therapy.
Note: Patients who have not received prior bevacizumab must be deemed medically inappropriate OR ineligible to receive bevacizumab, refused to receive bevacizumab, or been unable to receive bevacizumab due to lack of access.
- Measurable disease according to RECIST v1.1 criteria
- Normal gastrointestinal function.
- At least 28 days between termination of prior anticancer or hormonal therapy and first administration of batiraxcept.
- Full recovery from all treatment-related toxicities to Grade 1 or less, except alopecia.
- Tumors in the breast or bone
- Untreated central nervous system (CNS) metastases. Subjects requiring corticosteroid therapy for the management of their treated CNS metastases may not be on >10 mg/day prednisone or equivalent or have demonstrated signs or symptoms of neurologic instability for 28 days or less prior to randomization.
- Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen)
- Is being treated with concurrent anticancer therapy or other interventional treatments administered for their underlying ovarian cancer.
- Received prior therapy with PAC in the platinum-resistant recurrent setting
- Evidence of clinically significant third spacing (e.g., pleural effusions, ascites, anasarca, etc.) that requires therapeutic intervention within 28 days prior to first dose of batiraxcept/placebo
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo+PAC Placebo Placebo-controlled arm with PAC Batiraxcept+PAC Paclitaxel Combination of batiraxcept and PAC Placebo+PAC Paclitaxel Placebo-controlled arm with PAC Batiraxcept+PAC Batiraxcept Combination of batiraxcept and PAC
- Primary Outcome Measures
Name Time Method Anti-tumor activity of batiraxcept in combination with PAC measured by progression free survival (PFS) in patients receiving batiraxcept + PAC versus patients receiving Placebo+PAC 4 months PFS is the time interval between randomization and radiologically documented disease progression or death, whichever comes first.
- Secondary Outcome Measures
Name Time Method Overall survival 20 months Time following the treatment until death
Trial Locations
- Locations (149)
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
🇺🇸Los Angeles, California, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Columbus NCORP
🇺🇸Columbus, Ohio, United States
Women's Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Duke Cancer Center
🇺🇸Durham, North Carolina, United States
Stephenson Cancer Center - University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Wojewódzkie Wielospecjalistyczne Centrum Onkologii
🇵🇱Łódź, Poland
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Women & Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
LTD Caucasus Medical Centre
🇬🇪Tbilisi, Georgia
Providence Cancer Institute Franz Clinic
🇺🇸Portland, Oregon, United States
Southeastern Regional Medical Center, LLC
🇺🇸Newnan, Georgia, United States
University of South Alabama Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
Disney Family Cancer Center
🇺🇸Burbank, California, United States
Stanford Women's Cancer Center
🇺🇸Palo Alto, California, United States
Olive View UCLA Medical Center
🇺🇸Sylmar, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Florida Cancer Specialists
🇺🇸West Palm Beach, Florida, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Dr. Sudarshan K. Sharma, Ltd.
🇺🇸Hinsdale, Illinois, United States
Willis-Knighton Physician Network
🇺🇸Shreveport, Louisiana, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Maine Medical Partners - Women's Health - Division of Gynecologic Oncology
🇺🇸Scarborough, Maine, United States
Greater Baltimore Medical Center
🇺🇸Baltimore, Maryland, United States
Holy Cross Hospital
🇺🇸Silver Spring, Maryland, United States
Dana Farber Cancer Institute (DFCI)
🇺🇸Boston, Massachusetts, United States
Center of Hope
🇺🇸Reno, Nevada, United States
Metro Minnesota Community Oncology Research Consortium
🇺🇸Saint Louis Park, Minnesota, United States
Mercy Hospital, David C Pratt Cancer Center
🇺🇸Saint Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Optimum Clinical Research Group, LLC
🇺🇸Albuquerque, New Mexico, United States
The Blavatnik Family-Chelsea Medical Center at Mount Sinai
🇺🇸New York, New York, United States
North Shore Hematology Oncology Assoc. DBA NY Cancer and Blood Specialists
🇺🇸Port Jefferson Station, New York, United States
Miami Valley Hospital South
🇺🇸Centerville, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Ohio State University (OSU) Wexner Medical Center OSU Gynecologic Oncology at Mill Run
🇺🇸Columbus, Ohio, United States
Kettering Cancer Center
🇺🇸Kettering, Ohio, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
University of Tennessee
🇺🇸Knoxville, Tennessee, United States
Chattanooga's Program in Women's Oncology
🇺🇸Chattanooga, Tennessee, United States
Tennessee Oncology PLLC
🇺🇸Nashville, Tennessee, United States
Carilion Clinic Gynecology Oncology
🇺🇸Roanoke, Virginia, United States
Pro Healthcare Waukesha Memorial Hospital
🇺🇸Waukesha, Wisconsin, United States
Swedish Cancer Institute
🇺🇸Seattle, Washington, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
AZ St Jan Brugge
🇧🇪Brugge, Belgium
UCL St Luc
🇧🇪Bruxelles, Belgium
AZ Maria Middelares
🇧🇪Gent, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
CHC Liege
🇧🇪Liege, Belgium
CHU UCL Namur St. Elisabeth
🇧🇪Namur, Belgium
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Zhejiang, Hangzhou Province, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Clinical Research Unit, Jewish General Hospital
🇨🇦Montréal, Quebec, Canada
Sunnybrook Research Institute
🇨🇦Toronto, Ontario, Canada
First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Sun Yat-sen Memorial Hospital
🇨🇳Guangzhou, Yuexiu District, Guangdong Province, China
The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine
🇨🇳Xi'an, Shanxi, China
Fudan University Shanghai Cancer Hospital
🇨🇳Shanghai, Xuhui District, China
Nantong Tumor Hospital
🇨🇳Nantong, Tongzhou District, Jiangsu Province, China
Fakultni Nemocnice Olomouc
🇨🇿Olomouc, Czechia
UG Prague
🇨🇿Prague, Czechia
ICANS
🇫🇷Strasbourg, France
LTD Tbilisi Oncology
🇬🇪Tbilisi, Georgia
IRCCS Ist. Romagnolo per lo studio dei Tumori "Dino Amadori"
🇮🇹Meldola, Italy
VHIO
🇪🇸Barcelona, Spain
IEO - Istituto Europeo di Oncologia
🇮🇹Milan, Italy
Nuovo Ospedale Santo Stefano di Prato
🇮🇹Prato, Italy
Szpitale Pomorskie Sp. z o.o.
🇵🇱Gdynia, Poland
SPSK Nr 2 PUM Klinika Ginekologii Operacyjnej i Onkologii Klinicznej
🇵🇱Szczecin, Poland
UCK Centrum Medycyny
🇵🇱Gdańsk, Poland
Maria Sklodowska - Curie Instytute Oncolgy Center
🇵🇱Warsaw, Poland
Hospital Universitario Reina Sofia (Provincial)
🇪🇸Cordoba, Spain
Hospital San Pedro de Alcántara
🇪🇸Cáceres, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Spain
Institut Catala d'Oncologia
🇪🇸Girona, Spain
ICO
🇪🇸Hospitalet de Llobregat, Spain
Hospital Son Espases
🇪🇸Palma De Mallorca, Spain
Clinica Universidad de Navarra
🇪🇸Pamplona, Spain
IVO (Instituto Valenciano de Oncología)
🇪🇸Valencia, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Royal United Hospital Bath NHS Foundation Trust
🇬🇧Bath, United Kingdom
The Royal Marsden NHS Foundation Trust (Fulham Road)
🇬🇧London, United Kingdom
Clatterbridge Cancer Centre
🇬🇧Liverpool, United Kingdom
North Shore University Health System
🇺🇸Evanston, Illinois, United States
Midwestern Regional Medical Center, LLC
🇺🇸Zion, Illinois, United States
Magee Women's Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
West Penn Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
The Valley Hospital - Luckow Pavilion
🇺🇸Paramus, New Jersey, United States
University of California, San Francisco - Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
University of Wisconsin Clinical Science Center
🇺🇸Madison, Wisconsin, United States
UCLA Women's Health Clinical Research Unit
🇺🇸Los Angeles, California, United States
UC Irvine Health-Chao Family Comprehensive Cancer Center
🇺🇸Orange, California, United States
Banner MD Anderson Cancer Center/North Colorado Medical Center
🇺🇸Greeley, Colorado, United States
Georgia Cancer Center at Augusta University
🇺🇸Augusta, Georgia, United States
Baptist MD Anderson Cancer Center
🇺🇸Jacksonville, Florida, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System, Inc.
🇺🇸Savannah, Georgia, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Community Health Network
🇺🇸Indianapolis, Indiana, United States
St. Elizabeth Healthcare
🇺🇸Edgewood, Kentucky, United States
St Vincent Hospital and Healthcare Center
🇺🇸Indianapolis, Indiana, United States
Women's Cancer Care
🇺🇸Covington, Louisiana, United States
Beth Israel Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital
🇺🇸South Weymouth, Massachusetts, United States
Washington University School of Medicine - Division of Gynecologic Oncology
🇺🇸Saint Louis, Missouri, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Gabrail Cancer Center Research
🇺🇸Canton, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC
🇺🇸Tulsa, Oklahoma, United States
Sanford Gynecology Oncology Clinic
🇺🇸Sioux Falls, South Dakota, United States
ZNA Middelheim
🇧🇪Antwerpen, Belgium
CHA Libramont
🇧🇪Libramont, Belgium
Princess Margaret Cancer Center
🇨🇦Toronto, Ontario, Canada
Peking University Cancer Hospital
🇨🇳Beijing, Haidian District, China
Tianjin Cancer Hospital
🇨🇳Tianjin, Hexi District, China
Qilu Hospital Of Shandong University
🇨🇳Jinan, Shandong, China
The First Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Zhejiang, Shangcheng District, Hangzhou Province, China
The Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Xinghualing District, Shanxi Province, China
Hunan Cancer Hospital
🇨🇳Changsha, Yuelu District, Hunan Province, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Yuexiu District, China
Fakul Nemocnice Hradec Kralove
🇨🇿Hradec Králové, Czechia
FN Ostrava-Poruba
🇨🇿Ostrava, Czechia
LTD High Technology Hospital Medcenter
🇬🇪Batumi, Georgia
LTD Aversi Clinic
🇬🇪Tbilisi, Georgia
LTD Innova
🇬🇪Tbilisi, Georgia
LTD Consilium Medulla - Multiprofile Clinic
🇬🇪Tbilisi, Georgia
Policlinico S. Orsola-Malpighi - SSD Oncologia Medica
🇮🇹Bologna, Italy
Ist. di Candiolo - IRCCS Fondazione del Piemonte per l'Oncologia
🇮🇹Candiolo, Italy
IRCCS
🇮🇹Napoli, Italy
Ospedale "Vito Fazzi" - ASL Lecce
🇮🇹Lecce, Italy
SC Oncologia - Ospedale San Luca
🇮🇹Lucca, Italy
Fondazione Policlinico "Agostino Gemelli" IRCCS
🇮🇹Rome, Italy
South West Wales Cancer Institute
🇬🇧Swansea, United Kingdom
The Royal Marsden NHS Foundation Trust (Sutton)
🇬🇧London, United Kingdom
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
First Health of the Carolinas
🇺🇸Pinehurst, North Carolina, United States
Abington Memorial Hospital, Hanjani Institute for Gyn Onc
🇺🇸Willow Grove, Pennsylvania, United States
Cox Health
🇺🇸Springfield, Missouri, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
AdventHealth Gynecologic Oncology
🇺🇸Orlando, Florida, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
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