Clinical trial NCT04729608: Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer
Official title: A Phase 3, Randomized, Double-Blind, Placebo/Paclitaxel-Controlled Study of Batiraxcept (AVB-S6-500) in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer (AXLerate-OC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Platinum-resistant Ovarian Cancer
Keywords: Ovarian cancer
Platinum resistant
Recurrent ovarian cancer
High-grade serous adenocarcinoma
Lead sponsor: Aravive, Inc.
Sponsor class: INDUSTRY
Collaborators: name: GOG Foundation
name: European Network of Gynaecological Oncological Trial Groups (ENGOT)
First posted: 2021-01-28
Enrollment: 366
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: 4 months
Secondary outcomes:
measure: Overall survival
timeFrame: 20 months
Other outcomes:
measure: Duration of response (DOR)
timeFrame: 9 months
measure: Objective response rate (ORR)
timeFrame: 3 months
measure: Incidence of Treatment Emergent Adverse Events (TEAEs)
timeFrame: 10 months
measure: Quality of Life (QOL)
timeFrame: 10 months
measure: Clinical benefit rate (CBR)
timeFrame: 4 months
measure: Area under the batiraxcept concentration-time curve.
timeFrame: 10 months
measure: Maximum observed batiraxcept concentration.
timeFrame: 10 months
measure: Minimum observed batiraxcept concentration.
timeFrame: 10 months
measure: Pharmacodynamic marker assessment
timeFrame: 10 months
measure: Anti-drug antibody (ADA) titers
timeFrame: 10 months
measure: Cancer antigen 125 (CA-125) levels
timeFrame: 10 months
Locations:
city: Mobile
country: United States
facility: University of South Alabama Mitchell Cancer Institute
state: Alabama
city: Burbank
country: United States
facility: Disney Family Cancer Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
state: California
city: Los Angeles
country: United States
facility: UCLA Women's Health Clinical Research Unit
state: California
city: Orange
country: United States
facility: UC Irvine Health-Chao Family Comprehensive Cancer Center
state: California
city: Palo Alto
country: United States
facility: Stanford Women's Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco - Helen Diller Family Comprehensive Cancer Center
state: California
city: Sylmar
country: United States
facility: Olive View UCLA Medical Center
state: California
city: Greeley
country: United States
facility: Banner MD Anderson Cancer Center/North Colorado Medical Center
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Comprehensive Cancer Center
state: Florida
city: Orlando
country: United States
facility: AdventHealth Gynecologic Oncology
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Newnan
country: United States
facility: Southeastern Regional Medical Center, LLC
state: Georgia
city: Savannah
country: United States
facility: Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System, Inc.
state: Georgia
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Evanston
country: United States
facility: North Shore University Health System
state: Illinois
city: Hinsdale
country: United States
facility: Dr. Sudarshan K. Sharma, Ltd.
state: Illinois
city: Zion
country: United States
facility: Midwestern Regional Medical Center, LLC
state: Illinois
city: Indianapolis
country: United States
facility: Community Health Network
state: Indiana
city: Indianapolis
country: United States
facility: St Vincent Hospital and Healthcare Center
state: Indiana
city: Edgewood
country: United States
facility: St. Elizabeth Healthcare
state: Kentucky
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Covington
country: United States
facility: Women's Cancer Care
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton Physician Network
state: Louisiana
city: Scarborough
country: United States
facility: Maine Medical Partners - Women's Health - Division of Gynecologic Oncology
state: Maine
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Silver Spring
country: United States
facility: Holy Cross Hospital
state: Maryland
city: Boston
country: United States
facility: Beth Israel Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute (DFCI)
state: Massachusetts
city: South Weymouth
country: United States
facility: Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis Park
country: United States
facility: Metro Minnesota Community Oncology Research Consortium
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine - Division of Gynecologic Oncology
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital, David C Pratt Cancer Center
state: Missouri
city: Springfield
country: United States
facility: Cox Health
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Las Vegas
country: United States
facility: Women's Cancer Center of Nevada
state: Nevada
city: Reno
country: United States
facility: Center of Hope
state: Nevada
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Paramus
country: United States
facility: The Valley Hospital - Luckow Pavilion
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: Optimum Clinical Research Group, LLC
state: New Mexico
city: New York
country: United States
facility: The Blavatnik Family-Chelsea Medical Center at Mount Sinai
state: New York
city: Port Jefferson Station
country: United States
facility: North Shore Hematology Oncology Assoc. DBA NY Cancer and Blood Specialists
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
city: Pinehurst
country: United States
facility: First Health of the Carolinas
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Centerville
country: United States
facility: Miami Valley Hospital South
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio State University (OSU) Wexner Medical Center OSU Gynecologic Oncology at Mill Run
state: Ohio
city: Columbus
country: United States
facility: Columbus NCORP
state: Ohio
city: Kettering
country: United States
facility: Kettering Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center - University of Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC
state: Oklahoma
city: Portland
country: United States
facility: Providence Cancer Institute Franz Clinic
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee Women's Hospital of UPMC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: West Penn Hospital
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Memorial Hospital, Hanjani Institute for Gyn Onc
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Gynecology Oncology Clinic
state: South Dakota
city: Chattanooga
country: United States
facility: Chattanooga's Program in Women's Oncology
state: Tennessee
city: Knoxville
country: United States
facility: University of Tennessee
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology PLLC
state: Tennessee
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic Gynecology Oncology
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin Clinical Science Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Waukesha
country: United States
facility: Pro Healthcare Waukesha Memorial Hospital
state: Wisconsin
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Brugge
country: Belgium
facility: AZ St Jan Brugge
city: Bruxelles
country: Belgium
facility: UCL St Luc
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Leuven
country: Belgium
facility: UZ Leuven
city: Libramont
country: Belgium
facility: CHA Libramont
city: Liege
country: Belgium
facility: CHC Liege
city: Namur
country: Belgium
facility: CHU UCL Namur St. Elisabeth
city: Toronto
country: Canada
facility: Sunnybrook Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Montréal
country: Canada
facility: Clinical Research Unit, Jewish General Hospital
state: Quebec
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Haidian District
city: Zhejiang
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Hangzhou Province
city: Tianjin
country: China
facility: Tianjin Cancer Hospital
state: Hexi District
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Suzhou
country: China
facility: First Affiliated Hospital of Soochow University
state: Jiangsu
city: Jinan
country: China
facility: Qilu Hospital Of Shandong University
state: Shandong
city: Zhejiang
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Shangcheng District, Hangzhou Province
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine
state: Shanxi
city: Nantong
country: China
facility: Nantong Tumor Hospital
state: Tongzhou District, Jiangsu Province
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
state: Xinghualing District, Shanxi Province
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Hospital
state: Xuhui District
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Yuelu District, Hunan Province
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Yuexiu District, Guangdong Province
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Yuexiu District
city: Hradec Králové
country: Czechia
facility: Fakul Nemocnice Hradec Kralove
city: Olomouc
country: Czechia
facility: Fakultni Nemocnice Olomouc
city: Ostrava
country: Czechia
facility: FN Ostrava-Poruba
city: Prague
country: Czechia
facility: UG Prague
city: Strasbourg
country: France
facility: ICANS
city: Batumi
country: Georgia
facility: LTD High Technology Hospital Medcenter
city: Tbilisi
country: Georgia
facility: LTD Tbilisi Oncology
city: Tbilisi
country: Georgia
facility: LTD Aversi Clinic
city: Tbilisi
country: Georgia
facility: LTD Consilium Medulla - Multiprofile Clinic
city: Tbilisi
country: Georgia
facility: LTD Caucasus Medical Centre
city: Tbilisi
country: Georgia
facility: LTD Innova
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi - SSD Oncologia Medica
city: Candiolo
country: Italy
facility: Ist. di Candiolo - IRCCS Fondazione del Piemonte per l'Oncologia
city: Lecce
country: Italy
facility: Ospedale "Vito Fazzi" - ASL Lecce
city: Lucca
country: Italy
facility: SC Oncologia - Ospedale San Luca
city: Meldola
country: Italy
facility: IRCCS Ist. Romagnolo per lo studio dei Tumori "Dino Amadori"
city: Milan
country: Italy
facility: IEO - Istituto Europeo di Oncologia
city: Napoli
country: Italy
facility: IRCCS
city: Prato
country: Italy
facility: Nuovo Ospedale Santo Stefano di Prato
city: Rome
country: Italy
facility: Fondazione Policlinico "Agostino Gemelli" IRCCS
city: Gdańsk
country: Poland
facility: UCK Centrum Medycyny
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o.
city: Szczecin
country: Poland
facility: SPSK Nr 2 PUM Klinika Ginekologii Operacyjnej i Onkologii Klinicznej
city: Warsaw
country: Poland
facility: Maria Sklodowska - Curie Instytute Oncolgy Center
city: Łódź
country: Poland
facility: Wojewódzkie Wielospecjalistyczne Centrum Onkologii
city: Barcelona
country: Spain
facility: VHIO
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia (Provincial)
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Girona
country: Spain
facility: Institut Catala d'Oncologia
city: Hospitalet de Llobregat
country: Spain
facility: ICO
city: Madrid
country: Spain
facility: Clinica Universidad de Navarra
city: Madrid
country: Spain
facility: Hospital La Paz
city: Palma De Mallorca
country: Spain
facility: Hospital Son Espases
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Valencia
country: Spain
facility: IVO (Instituto Valenciano de Oncología)
city: Bath
country: United Kingdom
facility: Royal United Hospital Bath NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Clatterbridge Cancer Centre
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust (Sutton)
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust (Fulham Road)
city: Swansea
country: United Kingdom
facility: South West Wales Cancer Institute
Study officials:
References: