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

Sponsor
Aravive, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04729608
Collaborator
GOG Foundation (Other), European Network of Gynaecological Oncological Trial Groups (ENGOT) (Other)
350
Enrollment
135
Locations
2
Arms
38.3
Anticipated Duration (Months)
2.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Apr 22, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

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

    Drug: Paclitaxel
    Paclitaxel is the standard of care, background therapy
    Other Names:
  • Taxol

    • Other: Placebo
    Matching placebo

    Outcome Measures

    Primary Outcome Measures

    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 [4 months]

      PFS is the time interval between randomization and radiologically documented disease progression or death, whichever comes first.

    Secondary Outcome Measures

    1. Overall survival [20 months]

      Time following the treatment until death

    Other Outcome Measures

    1. Duration of response (DOR) [9 months]

      Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.

    2. Objective response rate (ORR) [3 months]

      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. Incidence of Treatment Emergent Adverse Events (TEAEs) [10 months]

    4. Quality of Life (QOL) [10 months]

      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).

    5. Clinical benefit rate (CBR) [4 months]

    6. Area under the batiraxcept concentration-time curve. [10 months]

    7. Maximum observed batiraxcept concentration. [10 months]

    8. Minimum observed batiraxcept concentration. [10 months]

    9. Pharmacodynamic marker assessment [10 months]

      Change from the baseline in GAS6 serum levels.

    10. Anti-drug antibody (ADA) titers [10 months]

    11. Cancer antigen 125 (CA-125) levels [10 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of South Alabama Mitchell Cancer Institute Mobile Alabama United States 36604
    2 Disney Family Cancer Center Burbank California United States 91505
    3 Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute Los Angeles California United States 90048
    4 UCLA Women's Health Clinical Research Unit Los Angeles California United States 90095
    5 UC Irvine Health-Chao Family Comprehensive Cancer Center Orange California United States 92868
    6 Stanford Women's Cancer Center Palo Alto California United States 94304
    7 Olive View UCLA Medical Center Sylmar California United States 91342
    8 Banner MD Anderson Cancer Center/North Colorado Medical Center Greeley Colorado United States 80631
    9 Hartford Hospital Hartford Connecticut United States 06106
    10 Yale University School of Medicine New Haven Connecticut United States 06520
    11 Baptist MD Anderson Cancer Center Jacksonville Florida United States 32207
    12 Mount Sinai Comprehensive Cancer Center Miami Beach Florida United States 33140
    13 AdventHealth Gynecologic Oncology Orlando Florida United States 32804
    14 Florida Cancer Specialists West Palm Beach Florida United States 33401
    15 Georgia Cancer Center at Augusta University Augusta Georgia United States 30912
    16 Northeast Georgia Medical Center Gainesville Georgia United States 30501
    17 Southeastern Regional Medical Center, LLC Newnan Georgia United States 30265
    18 Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System, Inc. Savannah Georgia United States 31405
    19 The University of Chicago Medical Center Chicago Illinois United States 60637
    20 North Shore University Health System Evanston Illinois United States 60201
    21 Dr. Sudarshan K. Sharma, Ltd. Hinsdale Illinois United States 60521
    22 Midwestern Regional Medical Center, LLC Zion Illinois United States 60099
    23 Community Health Network Indianapolis Indiana United States 46250
    24 St Vincent Hospital and Healthcare Center Indianapolis Indiana United States 46260
    25 St. Elizabeth Healthcare Edgewood Kentucky United States 41017
    26 Baptist Health Lexington Lexington Kentucky United States 40503
    27 Women's Cancer Care Covington Louisiana United States 70433
    28 Willis-Knighton Physician Network Shreveport Louisiana United States 71103
    29 Maine Medical Partners - Women's Health - Division of Gynecologic Oncology Scarborough Maine United States 04074
    30 Greater Baltimore Medical Center Baltimore Maryland United States 21204
    31 Holy Cross Hospital Silver Spring Maryland United States 20910
    32 Beth Israel Hospital Boston Massachusetts United States 02215
    33 Dana Farber Cancer Institute (DFCI) Boston Massachusetts United States 02215
    34 Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital South Weymouth Massachusetts United States 02190
    35 Baystate Medical Center Springfield Massachusetts United States 01199
    36 University of Michigan Ann Arbor Michigan United States 48109
    37 Mayo Clinic Rochester Minnesota United States 55905
    38 Metro Minnesota Community Oncology Research Consortium Saint Louis Park Minnesota United States 55416
    39 Washington University School of Medicine - Division of Gynecologic Oncology Saint Louis Missouri United States 63110
    40 Mercy Hospital, David C Pratt Cancer Center Saint Louis Missouri United States 63141
    41 Cox Health Springfield Missouri United States 65807
    42 Billings Clinic Billings Montana United States 07450
    43 Women's Cancer Center of Nevada Las Vegas Nevada United States 89169
    44 Center of Hope Reno Nevada United States 89511
    45 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    46 The Valley Hospital - Luckow Pavilion Paramus New Jersey United States 07652
    47 Holy Name Medical Center Teaneck New Jersey United States 07666
    48 Optimum Clinical Research Group, LLC Albuquerque New Mexico United States 87109
    49 The Blavatnik Family-Chelsea Medical Center at Mount Sinai New York New York United States 10011
    50 North Shore Hematology Oncology Assoc. DBA NY Cancer and Blood Specialists Port Jefferson Station New York United States 11776
    51 University of Rochester Medical Center Rochester New York United States 14620
    52 Stony Brook University Hospital Stony Brook New York United States 11793-7263
    53 Duke Cancer Center Durham North Carolina United States 27710
    54 First Health of the Carolinas Pinehurst North Carolina United States 28374
    55 Gabrail Cancer Center Research Canton Ohio United States 44718
    56 Miami Valley Hospital South Centerville Ohio United States 45459
    57 University of Cincinnati Cincinnati Ohio United States 45267
    58 Columbus NCORP Columbus Ohio United States 43215
    59 Kettering Cancer Center Kettering Ohio United States 45429
    60 Stephenson Cancer Center - University of Oklahoma Oklahoma City Oklahoma United States 73104
    61 Oklahoma Cancer Specialists and Research Institute, LLC Tulsa Oklahoma United States 74146
    62 Providence Cancer Institute Franz Clinic Portland Oregon United States 97213
    63 University of Pennsylvania Health System Philadelphia Pennsylvania United States 19104
    64 Magee Women's Hospital of UPMC Pittsburgh Pennsylvania United States 15213
    65 West Penn Hospital Pittsburgh Pennsylvania United States 15224
    66 Abington Memorial Hospital, Hanjani Institute for Gyn Onc Willow Grove Pennsylvania United States 19090
    67 Lankenau Medical Center Wynnewood Pennsylvania United States 19096
    68 Women & Infants Hospital of Rhode Island Providence Rhode Island United States 02905
    69 Medical University of South Carolina Charleston South Carolina United States 29425
    70 Sanford Gynecology Oncology Clinic Sioux Falls South Dakota United States 57104
    71 Chattanooga's Program in Women's Oncology Chattanooga Tennessee United States 37403
    72 University of Tennessee Knoxville Tennessee United States 37920
    73 Tennessee Oncology PLLC Nashville Tennessee United States 37203
    74 Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas United States 75246
    75 Virginia Commonwealth University Richmond Virginia United States 23298
    76 Carilion Clinic Gynecology Oncology Roanoke Virginia United States 24016
    77 Swedish Cancer Institute Seattle Washington United States 98104
    78 Seattle Cancer Care Alliance Seattle Washington United States 98195
    79 West Virginia University Morgantown West Virginia United States 26506
    80 University of Wisconsin Clinical Science Center Madison Wisconsin United States 53792
    81 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    82 Pro Healthcare Waukesha Memorial Hospital Waukesha Wisconsin United States 53188
    83 UCL St Luc Bruxelles Belgium 1200
    84 AZ Maria Middelares Gent Belgium 9000
    85 UZ Leuven Leuven Belgium 3000
    86 CHA Libramont Libramont Belgium 6800
    87 CHU UCL Namur St. Elisabeth Namur Belgium 5000
    88 Sunnybrook Research Institute Toronto Ontario Canada M4N 3M5
    89 Peking University Cancer Hospital Beijing Haidian District China 100142
    90 The Second Affiliated Hospital of Zhejiang University School of Medicine Zhejiang Hangzhou Province China 310009
    91 Tianjin Cancer Hospital Tianjin Hexi District China 300060
    92 Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei China 430022
    93 First Affiliated Hospital of Soochow University Suzhou Jiangsu China 215006
    94 Qilu Hospital Of Shandong University Jinan Shandong China 200012
    95 The First Affiliated Hospital of Zhejiang University School of Medicine Zhejiang Shangcheng District, Hangzhou Province China 310003
    96 The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine Xi'an Shanxi China 710061
    97 Nantong Tumor Hospital Nantong Tongzhou District, Jiangsu Province China 226361
    98 The Second Hospital of Shanxi Medical University Taiyuan Xinghualing District, Shanxi Province China 030001
    99 Fudan University Shanghai Cancer Hospital Shanghai Xuhui District China 201321
    100 Hunan Cancer Hospital Changsha Yuelu District, Hunan Province China 410013
    101 Sun Yat-sen Memorial Hospital Guangzhou Yuexiu District, Guangdong Province China 510120
    102 Sun Yat-sen University Cancer Center Guangzhou Yuexiu District China 510060
    103 Fakul Nemocnice Hradec Kralove Hradec Králové Czechia 50005
    104 Fakultni Nemocnice Olomouc Olomouc Czechia 77900
    105 FN Ostrava-Poruba Ostrava Czechia 70852
    106 UG Prague Prague Czechia 12800
    107 ICANS Strasbourg France 67200
    108 LTD High Technology Hospital Medcenter Batumi Georgia 6000
    109 LTD Tbilisi Oncology Tbilisi Georgia 0159
    110 LTD Consilium Medulla - Multiprofile Clinic Tbilisi Georgia 0168
    111 LTD Caucasus Medical Centre Tbilisi Georgia 0186
    112 Policlinico S. Orsola-Malpighi - SSD Oncologia Medica Bologna Italy 40138
    113 Ist. di Candiolo - IRCCS Fondazione del Piemonte per l'Oncologia Candiolo Italy 10060
    114 SC Oncologia - Ospedale San Luca Lucca Italy 55100
    115 IEO - Istituto Europeo di Oncologia Milan Italy 20141
    116 IRCCS Napoli Italy 80131
    117 Nuovo Ospedale Santo Stefano di Prato Prato Italy 59100
    118 Fondazione Policlinico "Agostino Gemelli" IRCCS Rome Italy 00168
    119 UCK Centrum Medycyny Gdańsk Poland 84214
    120 SPSK Nr 2 PUM Klinika Ginekologii Operacyjnej i Onkologii Klinicznej Szczecin Poland 70-111
    121 Maria Sklodowska - Curie Instytute Oncolgy Center Warsaw Poland 02-781
    122 Wojewódzkie Wielospecjalistyczne Centrum Onkologii Łódź Poland 93-513
    123 VHIO Barcelona Spain 08035
    124 Hospital Universitario Reina Sofia (Provincial) Cordoba Spain 14004
    125 Hospital San Pedro de Alcántara Cáceres Spain 10003
    126 Hospital General Universitario de Elche Elche Spain 03203
    127 Institut Catala d'Oncologia Girona Spain 17007
    128 ICO Hospitalet de Llobregat Spain 08908
    129 Clinica Universidad de Navarra Madrid Spain 28027
    130 Hospital La Paz Madrid Spain 28046
    131 Hospital Son Espases Palma De Mallorca Spain 07120
    132 Clinica Universidad de Navarra Pamplona Spain 31008
    133 Royal United Hospital Bath NHS Foundation Trust Bath United Kingdom BA1 3NG
    134 The Royal Marsden NHS Foundation Trust (Sutton) London United Kingdom SM2 5PT
    135 The Royal Marsden NHS Foundation Trust (Fulham Road) London United Kingdom SW3 6JJ

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Amy Franke, Aravive, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aravive, Inc.
    ClinicalTrials.gov Identifier:
    NCT04729608
    Other Study ID Numbers:
    • AVB500-OC-004
    • GOG-3059
    • ENGOT OV66
    • AXLerate-OC
    First Posted:
    Jan 28, 2021
    Last Update Posted:
    Jul 1, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Aravive, Inc.
    Ovarian cancer
    Platinum resistant
    Recurrent ovarian cancer
    High-grade serous adenocarcinoma
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial
    Paclitaxel

    Study Results

    No Results Posted as of Jul 1, 2022