Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer

Platinum-resistant Ovarian Cancer Clinical Trial

— AXLerate-OC  

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)

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
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Platinum-resistant Ovarian Cancer

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