Ovarian Cancer Clinical Trial

Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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 is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

350

Study ID:

NCT04729608

Recruitment Status:

Recruiting

Sponsor:

Aravive, Inc.

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There are 137 Locations for this study

See Locations Near You

University of South Alabama Mitchell Cancer Institute
Mobile Alabama, 36604, United States
Disney Family Cancer Center
Burbank California, 91505, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles California, 90048, United States
UCLA Women's Health Clinical Research Unit
Los Angeles California, 90095, United States
UC Irvine Health-Chao Family Comprehensive Cancer Center
Orange California, 92868, United States
Stanford Women's Cancer Center
Palo Alto California, 94304, United States
University of California, San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94158, United States
Olive View UCLA Medical Center
Sylmar California, 91342, United States
Banner MD Anderson Cancer Center/North Colorado Medical Center
Greeley Colorado, 80631, United States
Hartford Hospital
Hartford Connecticut, 06106, United States
Yale University School of Medicine
New Haven Connecticut, 06520, United States
Baptist MD Anderson Cancer Center
Jacksonville Florida, 32207, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach Florida, 33140, United States
AdventHealth Gynecologic Oncology
Orlando Florida, 32804, United States
Florida Cancer Specialists
West Palm Beach Florida, 33401, United States
Georgia Cancer Center at Augusta University
Augusta Georgia, 30912, United States
Northeast Georgia Medical Center
Gainesville Georgia, 30501, United States
Southeastern Regional Medical Center, LLC
Newnan Georgia, 30265, United States
Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System, Inc.
Savannah Georgia, 31405, United States
The University of Chicago Medical Center
Chicago Illinois, 60637, United States
North Shore University Health System
Evanston Illinois, 60201, United States
Dr. Sudarshan K. Sharma, Ltd.
Hinsdale Illinois, 60521, United States
Midwestern Regional Medical Center, LLC
Zion Illinois, 60099, United States
Community Health Network
Indianapolis Indiana, 46250, United States
St Vincent Hospital and Healthcare Center
Indianapolis Indiana, 46260, United States
St. Elizabeth Healthcare
Edgewood Kentucky, 41017, United States
Baptist Health Lexington
Lexington Kentucky, 40503, United States
Women's Cancer Care
Covington Louisiana, 70433, United States
Willis-Knighton Physician Network
Shreveport Louisiana, 71103, United States
Maine Medical Partners - Women's Health - Division of Gynecologic Oncology
Scarborough Maine, 04074, United States
Greater Baltimore Medical Center
Baltimore Maryland, 21204, United States
Holy Cross Hospital
Silver Spring Maryland, 20910, United States
Beth Israel Hospital
Boston Massachusetts, 02215, United States
Dana Farber Cancer Institute (DFCI)
Boston Massachusetts, 02215, United States
Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital
South Weymouth Massachusetts, 02190, United States
Baystate Medical Center
Springfield Massachusetts, 01199, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park Minnesota, 55416, United States
Washington University School of Medicine - Division of Gynecologic Oncology
Saint Louis Missouri, 63110, United States
Mercy Hospital, David C Pratt Cancer Center
Saint Louis Missouri, 63141, United States
Cox Health
Springfield Missouri, 65807, United States
Billings Clinic
Billings Montana, 07450, United States
Women's Cancer Center of Nevada
Las Vegas Nevada, 89169, United States
Center of Hope
Reno Nevada, 89511, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
The Valley Hospital - Luckow Pavilion
Paramus New Jersey, 07652, United States
Holy Name Medical Center
Teaneck New Jersey, 07666, United States
Optimum Clinical Research Group, LLC
Albuquerque New Mexico, 87109, United States
The Blavatnik Family-Chelsea Medical Center at Mount Sinai
New York New York, 10011, United States
North Shore Hematology Oncology Assoc. DBA NY Cancer and Blood Specialists
Port Jefferson Station New York, 11776, United States
University of Rochester Medical Center
Rochester New York, 14620, United States
Stony Brook University Hospital
Stony Brook New York, 11793, United States
Duke Cancer Center
Durham North Carolina, 27710, United States
First Health of the Carolinas
Pinehurst North Carolina, 28374, United States
Gabrail Cancer Center Research
Canton Ohio, 44718, United States
Miami Valley Hospital South
Centerville Ohio, 45459, United States
University of Cincinnati
Cincinnati Ohio, 45267, United States
Ohio State University (OSU) Wexner Medical Center OSU Gynecologic Oncology at Mill Run
Columbus Ohio, 43210, United States
Columbus NCORP
Columbus Ohio, 43215, United States
Kettering Cancer Center
Kettering Ohio, 45429, United States
Stephenson Cancer Center - University of Oklahoma
Oklahoma City Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa Oklahoma, 74146, United States
Providence Cancer Institute Franz Clinic
Portland Oregon, 97213, United States
University of Pennsylvania Health System
Philadelphia Pennsylvania, 19104, United States
Magee Women's Hospital of UPMC
Pittsburgh Pennsylvania, 15213, United States
West Penn Hospital
Pittsburgh Pennsylvania, 15224, United States
Abington Memorial Hospital, Hanjani Institute for Gyn Onc
Willow Grove Pennsylvania, 19090, United States
Lankenau Medical Center
Wynnewood Pennsylvania, 19096, United States
Women & Infants Hospital of Rhode Island
Providence Rhode Island, 02905, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Sanford Gynecology Oncology Clinic
Sioux Falls South Dakota, 57104, United States
Chattanooga's Program in Women's Oncology
Chattanooga Tennessee, 37403, United States
University of Tennessee
Knoxville Tennessee, 37920, United States
Tennessee Oncology PLLC
Nashville Tennessee, 37203, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
Virginia Commonwealth University
Richmond Virginia, 23298, United States
Carilion Clinic Gynecology Oncology
Roanoke Virginia, 24016, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Seattle Cancer Care Alliance
Seattle Washington, 98195, United States
West Virginia University
Morgantown West Virginia, 26506, United States
University of Wisconsin Clinical Science Center
Madison Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Pro Healthcare Waukesha Memorial Hospital
Waukesha Wisconsin, 53188, United States
UCL St Luc
Bruxelles , 1200, Belgium
AZ Maria Middelares
Gent , 9000, Belgium
UZ Leuven
Leuven , 3000, Belgium
CHA Libramont
Libramont , 6800, Belgium
CHU UCL Namur St. Elisabeth
Namur , 5000, Belgium
Sunnybrook Research Institute
Toronto Ontario, M4N 3, Canada
Princess Margaret Cancer Center
Toronto Ontario, M5G 2, Canada
Clinical Research Unit, Jewish General Hospital
Montréal Quebec, H3T 1, Canada
Peking University Cancer Hospital
Beijing Haidian District, 10014, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang Hangzhou Province, 31000, China
Tianjin Cancer Hospital
Tianjin Hexi District, 30006, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan Hubei, 43002, China
First Affiliated Hospital of Soochow University
Suzhou Jiangsu, 21500, China
Qilu Hospital Of Shandong University
Jinan Shandong, 20001, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang Shangcheng District, Hangzhou Province, 31000, China
The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine
Xi'an Shanxi, 71006, China
Nantong Tumor Hospital
Nantong Tongzhou District, Jiangsu Province, 22636, China
The Second Hospital of Shanxi Medical University
Taiyuan Xinghualing District, Shanxi Province, 03000, China
Fudan University Shanghai Cancer Hospital
Shanghai Xuhui District, 20132, China
Hunan Cancer Hospital
Changsha Yuelu District, Hunan Province, 41001, China
Sun Yat-sen Memorial Hospital
Guangzhou Yuexiu District, Guangdong Province, 51012, China
Sun Yat-sen University Cancer Center
Guangzhou Yuexiu District, 51006, China
Fakul Nemocnice Hradec Kralove
Hradec Králové , 50005, Czechia
Fakultni Nemocnice Olomouc
Olomouc , 77900, Czechia
FN Ostrava-Poruba
Ostrava , 70852, Czechia
UG Prague
Prague , 12800, Czechia
ICANS
Strasbourg , 67200, France
LTD High Technology Hospital Medcenter
Batumi , 6000, Georgia
LTD Tbilisi Oncology
Tbilisi , 0159, Georgia
LTD Consilium Medulla - Multiprofile Clinic
Tbilisi , 0168, Georgia
LTD Caucasus Medical Centre
Tbilisi , 0186, Georgia
Policlinico S. Orsola-Malpighi - SSD Oncologia Medica
Bologna , 40138, Italy
Ist. di Candiolo - IRCCS Fondazione del Piemonte per l'Oncologia
Candiolo , 10060, Italy
SC Oncologia - Ospedale San Luca
Lucca , 55100, Italy
IEO - Istituto Europeo di Oncologia
Milan , 20141, Italy
IRCCS
Napoli , 80131, Italy
Nuovo Ospedale Santo Stefano di Prato
Prato , 59100, Italy
Fondazione Policlinico "Agostino Gemelli" IRCCS
Rome , 00168, Italy
UCK Centrum Medycyny
Gdańsk , 84214, Poland
SPSK Nr 2 PUM Klinika Ginekologii Operacyjnej i Onkologii Klinicznej
Szczecin , 70-11, Poland
Maria Sklodowska - Curie Instytute Oncolgy Center
Warsaw , 02-78, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii
Łódź , 93-51, Poland
VHIO
Barcelona , 08035, Spain
Hospital Universitario Reina Sofia (Provincial)
Cordoba , 14004, Spain
Hospital San Pedro de Alcántara
Cáceres , 10003, Spain
Hospital General Universitario de Elche
Elche , 03203, Spain
Institut Catala d'Oncologia
Girona , 17007, Spain
ICO
Hospitalet de Llobregat , 08908, Spain
Clinica Universidad de Navarra
Madrid , 28027, Spain
Hospital La Paz
Madrid , 28046, Spain
Hospital Son Espases
Palma De Mallorca , 07120, Spain
Clinica Universidad de Navarra
Pamplona , 31008, Spain
Royal United Hospital Bath NHS Foundation Trust
Bath , BA1 3, United Kingdom
The Royal Marsden NHS Foundation Trust (Sutton)
London , SM2 5, United Kingdom
The Royal Marsden NHS Foundation Trust (Fulham Road)
London , SW3 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

350

Study ID:

NCT04729608

Recruitment Status:

Recruiting

Sponsor:


Aravive, Inc.

How clear is this clinincal trial information?

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