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

Primary Purpose

Platinum-resistant Ovarian Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Batiraxcept
Paclitaxel
Placebo
Sponsored by
Aravive, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Platinum-resistant Ovarian Cancer focused on measuring Ovarian cancer, Platinum resistant, Recurrent ovarian cancer, High-grade serous adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Alabama Mitchell Cancer Institute
  • Disney Family Cancer Center
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
  • UCLA Women's Health Clinical Research Unit
  • UC Irvine Health-Chao Family Comprehensive Cancer Center
  • Stanford Women's Cancer Center
  • University of California, San Francisco - Helen Diller Family Comprehensive Cancer Center
  • Olive View UCLA Medical Center
  • Banner MD Anderson Cancer Center/North Colorado Medical Center
  • Hartford Hospital
  • Yale University School of Medicine
  • Baptist MD Anderson Cancer Center
  • Mount Sinai Comprehensive Cancer Center
  • AdventHealth Gynecologic Oncology
  • Florida Cancer Specialists
  • Georgia Cancer Center at Augusta University
  • Northeast Georgia Medical Center
  • Southeastern Regional Medical Center, LLC
  • Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System, Inc.
  • The University of Chicago Medical Center
  • North Shore University Health System
  • Dr. Sudarshan K. Sharma, Ltd.
  • Midwestern Regional Medical Center, LLC
  • Community Health Network
  • St Vincent Hospital and Healthcare Center
  • St. Elizabeth Healthcare
  • Baptist Health Lexington
  • Women's Cancer Care
  • Willis-Knighton Physician Network
  • Maine Medical Partners - Women's Health - Division of Gynecologic Oncology
  • Greater Baltimore Medical Center
  • Holy Cross Hospital
  • Beth Israel Hospital
  • Dana Farber Cancer Institute (DFCI)
  • Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital
  • Baystate Medical Center
  • University of Michigan
  • Mayo Clinic
  • Metro Minnesota Community Oncology Research Consortium
  • Washington University School of Medicine - Division of Gynecologic Oncology
  • Mercy Hospital, David C Pratt Cancer Center
  • Cox Health
  • Billings Clinic
  • Women's Cancer Center of Nevada
  • Center of Hope
  • Rutgers Cancer Institute of New Jersey
  • The Valley Hospital - Luckow Pavilion
  • Holy Name Medical Center
  • Optimum Clinical Research Group, LLC
  • The Blavatnik Family-Chelsea Medical Center at Mount Sinai
  • North Shore Hematology Oncology Assoc. DBA NY Cancer and Blood Specialists
  • University of Rochester Medical Center
  • Stony Brook University Hospital
  • Duke Cancer Center
  • First Health of the Carolinas
  • Gabrail Cancer Center Research
  • Miami Valley Hospital South
  • University of Cincinnati
  • Ohio State University (OSU) Wexner Medical Center OSU Gynecologic Oncology at Mill Run
  • Columbus NCORP
  • Kettering Cancer Center
  • Stephenson Cancer Center - University of Oklahoma
  • Oklahoma Cancer Specialists and Research Institute, LLC
  • Providence Cancer Institute Franz Clinic
  • University of Pennsylvania Health System
  • Magee Women's Hospital of UPMC
  • West Penn Hospital
  • Abington Memorial Hospital, Hanjani Institute for Gyn Onc
  • Lankenau Medical Center
  • Women & Infants Hospital of Rhode Island
  • Medical University of South Carolina
  • Sanford Gynecology Oncology Clinic
  • Chattanooga's Program in Women's Oncology
  • University of Tennessee
  • Tennessee Oncology PLLC
  • Texas Oncology - Baylor Charles A. Sammons Cancer Center
  • Virginia Commonwealth University
  • Carilion Clinic Gynecology Oncology
  • Swedish Cancer Institute
  • Seattle Cancer Care Alliance
  • West Virginia University
  • University of Wisconsin Clinical Science Center
  • Medical College of Wisconsin
  • Pro Healthcare Waukesha Memorial Hospital
  • ZNA Middelheim
  • AZ St Jan Brugge
  • UCL St Luc
  • AZ Maria Middelares
  • UZ Leuven
  • CHA Libramont
  • CHC Liege
  • CHU UCL Namur St. Elisabeth
  • Sunnybrook Research Institute
  • Princess Margaret Cancer Center
  • Clinical Research Unit, Jewish General Hospital
  • Peking University Cancer Hospital
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Tianjin Cancer Hospital
  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
  • First Affiliated Hospital of Soochow University
  • Qilu Hospital Of Shandong University
  • The First Affiliated Hospital of Zhejiang University School of Medicine
  • The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine
  • Nantong Tumor Hospital
  • The Second Hospital of Shanxi Medical University
  • Fudan University Shanghai Cancer Hospital
  • Hunan Cancer Hospital
  • Sun Yat-sen Memorial Hospital
  • Sun Yat-sen University Cancer Center
  • Fakul Nemocnice Hradec Kralove
  • Fakultni Nemocnice Olomouc
  • FN Ostrava-Poruba
  • UG Prague
  • ICANS
  • LTD High Technology Hospital Medcenter
  • LTD Tbilisi Oncology
  • LTD Aversi Clinic
  • LTD Consilium Medulla - Multiprofile Clinic
  • LTD Caucasus Medical Centre
  • LTD Innova
  • Policlinico S. Orsola-Malpighi - SSD Oncologia Medica
  • Ist. di Candiolo - IRCCS Fondazione del Piemonte per l'Oncologia
  • Ospedale "Vito Fazzi" - ASL Lecce
  • SC Oncologia - Ospedale San Luca
  • IRCCS Ist. Romagnolo per lo studio dei Tumori "Dino Amadori"
  • IEO - Istituto Europeo di Oncologia
  • IRCCS
  • Nuovo Ospedale Santo Stefano di Prato
  • Fondazione Policlinico "Agostino Gemelli" IRCCS
  • UCK Centrum Medycyny
  • Szpitale Pomorskie Sp. z o.o.
  • SPSK Nr 2 PUM Klinika Ginekologii Operacyjnej i Onkologii Klinicznej
  • Maria Sklodowska - Curie Instytute Oncolgy Center
  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii
  • VHIO
  • Hospital Universitario Reina Sofia (Provincial)
  • Hospital San Pedro de Alcántara
  • Hospital General Universitario de Elche
  • Institut Catala d'Oncologia
  • ICO
  • Clinica Universidad de Navarra
  • Hospital La Paz
  • Hospital Son Espases
  • Clinica Universidad de Navarra
  • IVO (Instituto Valenciano de Oncología)
  • Royal United Hospital Bath NHS Foundation Trust
  • Clatterbridge Cancer Centre
  • The Royal Marsden NHS Foundation Trust (Sutton)
  • The Royal Marsden NHS Foundation Trust (Fulham Road)
  • South West Wales Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Batiraxcept+PAC

Placebo+PAC

Arm Description

Combination of batiraxcept and PAC

Placebo-controlled arm with PAC

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival
Time following the treatment until death

Full Information

First Posted
January 25, 2021
Last Updated
March 21, 2023
Sponsor
Aravive, Inc.
Collaborators
GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)
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1. Study Identification

Unique Protocol Identification Number
NCT04729608
Brief Title
Batiraxcept (AVB-S6-500)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aravive, Inc.
Collaborators
GOG Foundation, European Network of Gynaecological Oncological Trial Groups (ENGOT)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platinum-resistant Ovarian Cancer
Keywords
Ovarian cancer, Platinum resistant, Recurrent ovarian cancer, High-grade serous adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Batiraxcept+PAC
Arm Type
Experimental
Arm Description
Combination of batiraxcept and PAC
Arm Title
Placebo+PAC
Arm Type
Placebo Comparator
Arm Description
Placebo-controlled arm with PAC
Intervention Type
Drug
Intervention Name(s)
Batiraxcept
Other Intervention Name(s)
AVB-S6-500
Intervention Description
Batiraxcept is an experimental drug
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol
Intervention Description
Paclitaxel is the standard of care, background therapy
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
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
Description
PFS is the time interval between randomization and radiologically documented disease progression or death, whichever comes first.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Time following the treatment until death
Time Frame
20 months
Other Pre-specified Outcome Measures:
Title
Duration of response (DOR)
Description
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
Time Frame
9 months
Title
Objective response rate (ORR)
Description
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
Time Frame
3 months
Title
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame
10 months
Title
Quality of Life (QOL)
Description
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).
Time Frame
10 months
Title
Clinical benefit rate (CBR)
Time Frame
4 months
Title
Area under the batiraxcept concentration-time curve.
Time Frame
10 months
Title
Maximum observed batiraxcept concentration.
Time Frame
10 months
Title
Minimum observed batiraxcept concentration.
Time Frame
10 months
Title
Pharmacodynamic marker assessment
Description
Change from the baseline in GAS6 serum levels.
Time Frame
10 months
Title
Anti-drug antibody (ADA) titers
Time Frame
10 months
Title
Cancer antigen 125 (CA-125) levels
Time Frame
10 months

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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