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.
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
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There are 147 Locations for this study
Mobile Alabama, 36604, United States
Burbank California, 91505, United States
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
Orange California, 92868, United States
Palo Alto California, 94304, United States
San Francisco California, 94158, United States
Sylmar California, 91342, United States
Greeley Colorado, 80631, United States
Hartford Connecticut, 06106, United States
New Haven Connecticut, 06520, United States
Jacksonville Florida, 32207, United States
Miami Beach Florida, 33140, United States
Orlando Florida, 32804, United States
West Palm Beach Florida, 33401, United States
Augusta Georgia, 30912, United States
Gainesville Georgia, 30501, United States
Newnan Georgia, 30265, United States
Savannah Georgia, 31405, United States
Chicago Illinois, 60637, United States
Evanston Illinois, 60201, United States
Hinsdale Illinois, 60521, United States
Zion Illinois, 60099, United States
Indianapolis Indiana, 46250, United States
Indianapolis Indiana, 46260, United States
Edgewood Kentucky, 41017, United States
Lexington Kentucky, 40503, United States
Covington Louisiana, 70433, United States
Shreveport Louisiana, 71103, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21204, United States
Silver Spring Maryland, 20910, United States
Boston Massachusetts, 02215, United States
Boston Massachusetts, 02215, United States
South Weymouth Massachusetts, 02190, United States
Springfield Massachusetts, 01199, United States
Ann Arbor Michigan, 48109, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65807, United States
Billings Montana, 07450, United States
Las Vegas Nevada, 89169, United States
Reno Nevada, 89511, United States
New Brunswick New Jersey, 08903, United States
Paramus New Jersey, 07652, United States
Teaneck New Jersey, 07666, United States
Albuquerque New Mexico, 87109, United States
New York New York, 10011, United States
Port Jefferson Station New York, 11776, United States
Rochester New York, 14620, United States
Stony Brook New York, 11793, United States
Durham North Carolina, 27710, United States
Pinehurst North Carolina, 28374, United States
Canton Ohio, 44718, United States
Centerville Ohio, 45459, United States
Cincinnati Ohio, 45267, United States
Columbus Ohio, 43210, United States
Columbus Ohio, 43215, United States
Kettering Ohio, 45429, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74146, United States
Portland Oregon, 97213, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15224, United States
Willow Grove Pennsylvania, 19090, United States
Wynnewood Pennsylvania, 19096, United States
Providence Rhode Island, 02905, United States
Charleston South Carolina, 29425, United States
Sioux Falls South Dakota, 57104, United States
Chattanooga Tennessee, 37403, United States
Knoxville Tennessee, 37920, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75246, United States
Richmond Virginia, 23298, United States
Roanoke Virginia, 24016, United States
Seattle Washington, 98104, United States
Seattle Washington, 98195, United States
Morgantown West Virginia, 26506, United States
Madison Wisconsin, 53792, United States
Milwaukee Wisconsin, 53226, United States
Waukesha Wisconsin, 53188, United States
Antwerpen , 2020, Belgium
Brugge , 8000, Belgium
Bruxelles , 1200, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Libramont , 6800, Belgium
Liege , 4000, Belgium
Namur , 5000, Belgium
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montréal Quebec, H3T 1, Canada
Beijing Haidian District, 10014, China
Zhejiang Hangzhou Province, 31000, China
Tianjin Hexi District, 30006, China
Wuhan Hubei, 43002, China
Suzhou Jiangsu, 21500, China
Jinan Shandong, 20001, China
Zhejiang Shangcheng District, Hangzhou Province, 31000, China
Xi'an Shanxi, 71006, China
Nantong Tongzhou District, Jiangsu Province, 22636, China
Taiyuan Xinghualing District, Shanxi Province, 03000, China
Shanghai Xuhui District, 20132, China
Changsha Yuelu District, Hunan Province, 41001, China
Guangzhou Yuexiu District, Guangdong Province, 51012, China
Guangzhou Yuexiu District, 51006, China
Hradec Králové , 50005, Czechia
Olomouc , 77900, Czechia
Ostrava , 70852, Czechia
Prague , 12800, Czechia
Strasbourg , 67200, France
Batumi , 6000, Georgia
Tbilisi , 0159, Georgia
Tbilisi , 0160, Georgia
Tbilisi , 0168, Georgia
Tbilisi , 0186, Georgia
Tbilisi , 0186, Georgia
Bologna , 40138, Italy
Candiolo , 10060, Italy
Lecce , 73100, Italy
Lucca , 55100, Italy
Meldola , 47014, Italy
Milan , 20141, Italy
Napoli , 80131, Italy
Prato , 59100, Italy
Rome , 00168, Italy
Gdańsk , 84214, Poland
Gdynia , 81519, Poland
Szczecin , 70-11, Poland
Warsaw , 02-78, Poland
Łódź , 93-51, Poland
Barcelona , 08035, Spain
Cordoba , 14004, Spain
Cáceres , 10003, Spain
Elche , 03203, Spain
Girona , 17007, Spain
Hospitalet de Llobregat , 08908, Spain
Madrid , 28027, Spain
Madrid , 28046, Spain
Palma De Mallorca , 07120, Spain
Pamplona , 31008, Spain
Valencia , 46009, Spain
Bath , BA1 3, United Kingdom
Liverpool , L7 8Y, United Kingdom
London , SM2 5, United Kingdom
London , SW3 6, United Kingdom
Swansea , SA2 8, United Kingdom
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