Study Stopped
There were no significant differences in median PFS between batiraxcept + paclitaxel or paclitaxel alone arms. There was no detriment to overall survival. No new safety signals were identified.
Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer
AXLerate-OC
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)
4 other identifiers
interventional
366
11 countries
150
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2021
150 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2021
CompletedFirst Posted
Study publicly available on registry
January 28, 2021
CompletedStudy Start
First participant enrolled
April 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2023
CompletedOctober 30, 2023
October 1, 2023
2.3 years
January 25, 2021
October 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
PFS is the time interval between randomization and radiologically documented disease progression or death, whichever comes first.
4 months
Secondary Outcomes (1)
Overall survival
20 months
Other Outcomes (11)
Duration of response (DOR)
9 months
Objective response rate (ORR)
3 months
Incidence of Treatment Emergent Adverse Events (TEAEs)
10 months
- +8 more other outcomes
Study Arms (2)
Batiraxcept+PAC
EXPERIMENTALCombination of batiraxcept and PAC
Placebo+PAC
PLACEBO COMPARATORPlacebo-controlled arm with PAC
Interventions
Paclitaxel is the standard of care, background therapy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aravive, Inc.lead
- GOG Foundationcollaborator
- European Network of Gynaecological Oncological Trial Groups (ENGOT)collaborator
Study Sites (150)
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
Cox Health
Springfield, Missouri, 65807, United States
Washington University School of Medicine - Division of Gynecologic Oncology
St Louis, Missouri, 63110, United States
Mercy Hospital, David C Pratt Cancer Center
St Louis, Missouri, 63141, 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, 11793-7263, 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
ZNA Middelheim
Antwerp, 2020, Belgium
AZ St Jan Brugge
Bruges, 8000, Belgium
UCL St Luc
Brussels, 1200, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHA Libramont
Libramont, 6800, Belgium
CHC Liege
Liège, 4000, Belgium
CHU UCL Namur St. Elisabeth
Namur, 5000, Belgium
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9, Canada
Clinical Research Unit, Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Peking University Cancer Hospital
Beijing, Haidian District, 100142, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang, Hangzhou Province, 310009, China
Tianjin Cancer Hospital
Tianjin, Hexi District, 300060, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Qilu Hospital Of Shandong University
Jinan, Shandong, 200012, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang, Shangcheng District, Hangzhou Province, 310003, China
The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine
Xi’an, Shanxi, 710061, China
Nantong Tumor Hospital
Nantong, Tongzhou District, Jiangsu Province, 226361, China
The Second Hospital of Shanxi Medical University
Taiyuan, Xinghualing District, Shanxi Province, 030001, China
Fudan University Shanghai Cancer Hospital
Shanghai, Xuhui District, 201321, China
Hunan Cancer Hospital
Changsha, Yuelu District, Hunan Province, 410013, China
Sun Yat-sen Memorial Hospital
Guangzhou, Yuexiu District, Guangdong Province, 510120, China
Sun Yat-sen University Cancer Center
Guangzhou, Yuexiu District, 510060, 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 Aversi Clinic
Tbilisi, 0160, Georgia
LTD Consilium Medulla - Multiprofile Clinic
Tbilisi, 0168, Georgia
LTD Caucasus Medical Centre
Tbilisi, 0186, Georgia
LTD Innova
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
Ospedale "Vito Fazzi" - ASL Lecce
Lecce, 73100, Italy
SC Oncologia - Ospedale San Luca
Lucca, 55100, Italy
IRCCS Ist. Romagnolo per lo studio dei Tumori "Dino Amadori"
Meldola, 47014, 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
Gdansk, 84214, Poland
Szpitale Pomorskie Sp. z o.o.
Gdynia, 81519, Poland
Wojewódzkie Wielospecjalistyczne Centrum Onkologii
Lodz, 93-513, Poland
SPSK Nr 2 PUM Klinika Ginekologii Operacyjnej i Onkologii Klinicznej
Szczecin, 70-111, Poland
Maria Sklodowska - Curie Instytute Oncolgy Center
Warsaw, 02-781, Poland
VHIO
Barcelona, 08035, Spain
Hospital San Pedro de Alcántara
Cáceres, 10003, Spain
Hospital Universitario Reina Sofia (Provincial)
Córdoba, 14004, Spain
Hospital General Universitario de Elche
Elche, 03203, Spain
Institut Catala d'Oncologia
Girona, 17007, Spain
ICO
L'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
IVO (Instituto Valenciano de Oncología)
Valencia, 46009, Spain
Royal United Hospital Bath NHS Foundation Trust
Bath, BA1 3NG, United Kingdom
Clatterbridge Cancer Centre
Liverpool, L7 8YA, United Kingdom
The Royal Marsden NHS Foundation Trust (Sutton)
London, SM2 5PT, United Kingdom
The Royal Marsden NHS Foundation Trust (Fulham Road)
London, SW3 6JJ, United Kingdom
South West Wales Cancer Institute
Swansea, SA2 8QA, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2021
First Posted
January 28, 2021
Study Start
April 22, 2021
Primary Completion
August 4, 2023
Study Completion
August 4, 2023
Last Updated
October 30, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share