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)

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.

Study Overview

• Status: Terminated
• Conditions: Platinum-resistant Ovarian Cancer
• Intervention / Treatment: Other: Placebo; Drug: Batiraxcept; Drug: Paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 366
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2020
    • ZNA Middelheim
  • Brugge, Belgium, 8000
    • AZ St Jan Brugge
  • Bruxelles, Belgium, 1200
    • UCL St Luc
  • Gent, Belgium, 9000
    • AZ Maria Middelares
  • Leuven, Belgium, 3000
    • UZ Leuven
  • Libramont, Belgium, 6800
    • CHA Libramont
  • Liege, Belgium, 4000
    • CHC Liège
  • Namur, Belgium, 5000
    • CHU UCL Namur St. Elisabeth
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Center
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Research Institute
  • Quebec
    • Montréal, Quebec, Canada, H3T 1E2
      • Clinical Research Unit, Jewish General Hospital
• China
  • Haidian District
    • Beijing, Haidian District, China, 100142
      • Peking University Cancer Hospital
  • Hangzhou Province
    • Zhejiang, Hangzhou Province, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Hexi District
    • Tianjin, Hexi District, China, 300060
      • Tianjin Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • First Affiliated Hospital of Soochow University
  • Shandong
    • Jinan, Shandong, China, 200012
      • Qilu Hospital of Shandong University
  • Shangcheng District, Hangzhou Province
    • Zhejiang, Shangcheng District, Hangzhou Province, China, 310003
      • The First Affiliated Hospital of Zhejiang University School of Medicine
  • Shanxi
    • Xi'an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine
  • Tongzhou District, Jiangsu Province
    • Nantong, Tongzhou District, Jiangsu Province, China, 226361
      • Nantong Tumor Hospital
  • Xinghualing District, Shanxi Province
    • Taiyuan, Xinghualing District, Shanxi Province, China, 030001
      • The Second Hospital of Shanxi Medical University
  • Xuhui District
    • Shanghai, Xuhui District, China, 201321
      • Fudan University Shanghai Cancer Hospital
  • Yuelu District, Hunan Province
    • Changsha, Yuelu District, Hunan Province, China, 410013
      • Hunan Cancer Hospital
  • Yuexiu District
    • Guangzhou, Yuexiu District, China, 510060
      • Sun Yat-sen University Cancer Center
  • Yuexiu District, Guangdong Province
    • Guangzhou, Yuexiu District, Guangdong Province, China, 510120
      • Sun Yat-sen Memorial Hospital
• Czechia
  • Hradec Králové, Czechia, 50005
    • Fakul Nemocnice Hradec Kralove
  • Olomouc, Czechia, 77900
    • Fakultni Nemocnice Olomouc
  • Ostrava, Czechia, 70852
    • FN Ostrava-Poruba
  • Prague, Czechia, 12800
    • UG Prague
• France
  • Strasbourg, France, 67200
    • ICANS
• Georgia
  • Batumi, Georgia, 6000
    • LTD High Technology hospital Medcenter
  • Tbilisi, Georgia, 0160
    • LTD Aversi Clinic
  • Tbilisi, Georgia, 0186
    • LTD Caucasus Medical Centre
  • Tbilisi, Georgia, 0159
    • LTD Tbilisi Oncology
  • Tbilisi, Georgia, 0168
    • LTD Consilium Medulla - Multiprofile Clinic
  • Tbilisi, Georgia, 0186
    • Ltd Innova
• Italy
  • Bologna, Italy, 40138
    • Policlinico S. Orsola-Malpighi - SSD Oncologia Medica
  • Candiolo, Italy, 10060
    • Ist. di Candiolo - IRCCS Fondazione del Piemonte per l'Oncologia
  • Lecce, Italy, 73100
    • Ospedale "Vito Fazzi" - ASL Lecce
  • Lucca, Italy, 55100
    • SC Oncologia - Ospedale San Luca
  • Meldola, Italy, 47014
    • IRCCS Ist. Romagnolo per lo studio dei Tumori "Dino Amadori"
  • Milan, Italy, 20141
    • IEO - Istituto Europeo di Oncologia
  • Napoli, Italy, 80131
    • IRCCS
  • Prato, Italy, 59100
    • Nuovo Ospedale Santo Stefano di Prato
  • Rome, Italy, 00168
    • Fondazione Policlinico "Agostino Gemelli" IRCCS
• Poland
  • Gdańsk, Poland, 84214
    • UCK Centrum Medycyny
  • Gdynia, Poland, 81519
    • Szpitale Pomorskie Sp. z o.o.
  • Szczecin, Poland, 70-111
    • SPSK Nr 2 PUM Klinika Ginekologii Operacyjnej i Onkologii Klinicznej
  • Warsaw, Poland, 02-781
    • Maria Sklodowska - Curie Instytute Oncolgy Center
  • Łódź, Poland, 93-513
    • Wojewódzkie Wielospecjalistyczne Centrum Onkologii
• Spain
  • Barcelona, Spain, 08035
    • VHIO
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia (Provincial)
  • Cáceres, Spain, 10003
    • Hospital San Pedro de Alcántara
  • Elche, Spain, 03203
    • Hospital General Universitario de Elche
  • Girona, Spain, 17007
    • Institut Catala d'Oncologia
  • Hospitalet de Llobregat, Spain, 08908
    • ICO
  • Madrid, Spain, 28046
    • Hospital La Paz
  • Madrid, Spain, 28027
    • Clinica Universidad de Navarra
  • Palma De Mallorca, Spain, 07120
    • Hospital Son Espases
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra
  • Valencia, Spain, 46009
    • IVO (Instituto Valenciano de Oncología)
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Royal United Hospital Bath NHS Foundation Trust
  • Liverpool, United Kingdom, L7 8YA
    • Clatterbridge Cancer Centre
  • London, United Kingdom, SM2 5PT
    • The Royal Marsden NHS Foundation Trust (Sutton)
  • London, United Kingdom, SW3 6JJ
    • The Royal Marsden NHS Foundation Trust (Fulham Road)
  • Swansea, United Kingdom, SA2 8QA
    • South West Wales Cancer Institute
• United States
  • Alabama
    • Mobile, Alabama, United States, 36604
      • University of South Alabama Mitchell Cancer Institute
  • California
    • Burbank, California, United States, 91505
      • Disney Family Cancer Center
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
    • Los Angeles, California, United States, 90095
      • UCLA Women's Health Clinical Research Unit
    • Orange, California, United States, 92868
      • UC Irvine Health-Chao Family Comprehensive Cancer Center
    • Palo Alto, California, United States, 94304
      • Stanford Women's Cancer Center
    • San Francisco, California, United States, 94158
      • University of California, San Francisco - Helen Diller Family Comprehensive Cancer Center
    • Sylmar, California, United States, 91342
      • Olive View UCLA Medical Center
  • Colorado
    • Greeley, Colorado, United States, 80631
      • Banner MD Anderson Cancer Center/North Colorado Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Hospital
    • New Haven, Connecticut, United States, 06520
      • Yale University School Of Medicine
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist MD Anderson Cancer Center
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Comprehensive Cancer Center
    • Orlando, Florida, United States, 32804
      • AdventHealth Gynecologic Oncology
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Cancer Center at Augusta University
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
    • Newnan, Georgia, United States, 30265
      • Southeastern Regional Medical Center, LLC
    • Savannah, Georgia, United States, 31405
      • Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medical Center
    • Evanston, Illinois, United States, 60201
      • North Shore University Health System
    • Hinsdale, Illinois, United States, 60521
      • Dr. Sudarshan K. Sharma, Ltd.
    • Zion, Illinois, United States, 60099
      • Midwestern Regional Medical Center, LLC
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Community Health Network
    • Indianapolis, Indiana, United States, 46260
      • St Vincent Hospital and Healthcare Center
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Healthcare
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Women's Cancer Care
    • Shreveport, Louisiana, United States, 71103
      • Willis-Knighton Physician Network
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Medical Partners - Women's Health - Division of Gynecologic Oncology
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center
    • Silver Spring, Maryland, United States, 20910
      • Holy Cross Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute (DFCI)
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Hospital
    • South Weymouth, Massachusetts, United States, 02190
      • Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
    • Saint Louis Park, Minnesota, United States, 55416
      • Metro Minnesota Community Oncology Research Consortium
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine - Division of Gynecologic Oncology
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital, David C Pratt Cancer Center
    • Springfield, Missouri, United States, 65807
      • Cox Health
  • Montana
    • Billings, Montana, United States, 07450
      • Billings Clinic
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Women's Cancer Center of Nevada
    • Reno, Nevada, United States, 89511
      • Center of Hope
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Cancer Institute of New Jersey
    • Paramus, New Jersey, United States, 07652
      • The Valley Hospital - Luckow Pavilion
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Optimum Clinical Research Group, LLC
  • New York
    • New York, New York, United States, 10011
      • The Blavatnik Family-Chelsea Medical Center at Mount Sinai
    • Port Jefferson Station, New York, United States, 11776
      • North Shore Hematology Oncology Assoc. DBA NY Cancer and Blood Specialists
    • Rochester, New York, United States, 14620
      • University of Rochester Medical Center
    • Stony Brook, New York, United States, 11793-7263
      • Stony Brook University Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Cancer Center
    • Pinehurst, North Carolina, United States, 28374
      • First Health of the Carolinas
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research
    • Centerville, Ohio, United States, 45459
      • Miami Valley Hospital South
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
    • Columbus, Ohio, United States, 43215
      • Columbus NCORP
    • Columbus, Ohio, United States, 43210
      • Ohio State University (OSU) Wexner Medical Center OSU Gynecologic Oncology at Mill Run
    • Kettering, Ohio, United States, 45429
      • Kettering Cancer Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Stephenson Cancer Center - University of Oklahoma
    • Tulsa, Oklahoma, United States, 74146
      • Oklahoma Cancer Specialists and Research Institute, LLC
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Cancer Institute Franz Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System
    • Pittsburgh, Pennsylvania, United States, 15224
      • West Penn Hospital
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Women's Hospital of UPMC
    • Willow Grove, Pennsylvania, United States, 19090
      • Abington Memorial Hospital, Hanjani Institute for Gyn Onc
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women & Infants Hospital of Rhode Island
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Gynecology Oncology Clinic
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Chattanooga's Program in Women's Oncology
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology PLLC
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology - Baylor Charles A. Sammons Cancer Center
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
    • Roanoke, Virginia, United States, 24016
      • Carilion Clinic Gynecology Oncology
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute
    • Seattle, Washington, United States, 98195
      • Seattle Cancer Care Alliance
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Clinical Science Center
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Waukesha, Wisconsin, United States, 53188
      • Pro Healthcare Waukesha Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Batiraxcept+PAC; Combination of batiraxcept and PAC	Drug: Batiraxcept; Batiraxcept is an experimental drug; Other Names: AVB-S6-500; Drug: Paclitaxel; Paclitaxel is the standard of care, background therapy; Other Names: Taxol
Placebo Comparator: Placebo+PAC; Placebo-controlled arm with PAC	Other: Placebo; Matching placebo; Drug: Paclitaxel; Paclitaxel is the standard of care, background therapy; Other Names: Taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Time following the treatment until death	20 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of response (DOR)	Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.	9 months
Objective response rate (ORR)	Proportion of subjects who have a confirmed partial or complete response to therapy relative to baseline as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria	3 months
Incidence of Treatment Emergent Adverse Events (TEAEs)		10 months
Quality of Life (QOL)	Subject QOL will be assessed using the Functional Assessment Of Cancer Therapy - Ovarian Cancer (FACT-O) questionnaire, which consists of 4 subscales: physical well-being (7 questions), social/family well-being (7 questions), emotional well-being (6 questions), and functional well-being (7 questions), and 12 additional concerns specific to ovarian cancer. All items are rated on a 5 point scale with 0 "not at all" and 4 "very much". The scoring algorithm allows for eight summary scales: the four core well-being subscales, a subtotal of the 27 core items, a subtotal of the 12 ovarian-specific additional concerns, a grand total of the 39 items, and a trial outcome index (sum of the 17 physical and functional wellbeing items plus the 12 ovarian-specific items).	10 months
Clinical benefit rate (CBR)		4 months
Area under the batiraxcept concentration-time curve.		10 months
Maximum observed batiraxcept concentration.		10 months
Minimum observed batiraxcept concentration.		10 months
Pharmacodynamic marker assessment	Change from the baseline in GAS6 serum levels.	10 months
Anti-drug antibody (ADA) titers		10 months
Cancer antigen 125 (CA-125) levels		10 months

Collaborators and Investigators

• Sponsor: Aravive, Inc.
• Collaborators: GOG Foundation; European Network of Gynaecological Oncological Trial Groups (ENGOT)

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Actual): August 4, 2023
• Study Completion (Actual): August 4, 2023

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): January 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Ovarian cancer; Recurrent ovarian cancer; Platinum resistant; High-grade serous adenocarcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: AVB500-OC-004; GOG-3059 (Other Identifier: GOG Foundation); ENGOT OV66 (Other Identifier: ENGOT); AXLerate-OC (Other Identifier: Aravive)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No