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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04729608
Other study ID # AVB500-OC-004
Secondary ID GOG-3059ENGOT OV
Status Terminated
Phase Phase 3
First received
Last updated
Start date April 22, 2021
Est. completion date August 4, 2023

Study information

Verified date October 2023
Source Aravive, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 366
Est. completion date August 4, 2023
Est. primary completion date August 4, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Batiraxcept
Batiraxcept is an experimental drug
Paclitaxel
Paclitaxel is the standard of care, background therapy
Other:
Placebo
Matching placebo

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Aravive, Inc. European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  China,  Czechia,  France,  Georgia,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Other Incidence of Treatment Emergent Adverse Events (TEAEs) 10 months
Other 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
Other Clinical benefit rate (CBR) 4 months
Other Area under the batiraxcept concentration-time curve. 10 months
Other Maximum observed batiraxcept concentration. 10 months
Other Minimum observed batiraxcept concentration. 10 months
Other Pharmacodynamic marker assessment Change from the baseline in GAS6 serum levels. 10 months
Other Anti-drug antibody (ADA) titers 10 months
Other Cancer antigen 125 (CA-125) levels 10 months
Primary 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 Overall survival Time following the treatment until death 20 months
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