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Platinum-resistant Ovarian CancerPhase 3AXLerate-OCNCT04729608

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

A Phase 3 study testing Batiraxcept and Paclitaxel in people with Platinum-resistant Ovarian Cancer, run by Aravive, Inc. at 150 sites in 11 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Platinum-resistant Ovarian Cancer
What is being tested?
Batiraxcept and Paclitaxel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
366 participants
Where
150 sitesin 11 countries
Study dates
22 Apr 2021to 4 Aug 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

150 sites in 11 countries.

150 sites in 11 countries

United States84 sites

  • Optimum Clinical Research Group, LLC

    Albuquerque, New Mexico, 87109

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Billings Clinic

    Billings, Montana, 07450

  • Beth Israel Hospital

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute (DFCI)

    Boston, Massachusetts, 02215

  • Disney Family Cancer Center

    Burbank, California, 91505

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Chattanooga's Program in Women's Oncology

    Chattanooga, Tennessee, 37403

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Ohio State University (OSU) Wexner Medical Center OSU Gynecologic Oncology at Mill Run

    Columbus, Ohio, 43210

  • Columbus NCORP

    Columbus, Ohio, 43215

  • Women's Cancer Care

    Covington, Louisiana, 70433

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Duke Cancer Center

    Durham, North Carolina, 27710

  • St. Elizabeth Healthcare

    Edgewood, Kentucky, 41017

  • North Shore University Health System

    Evanston, Illinois, 60201

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Banner MD Anderson Cancer Center/North Colorado Medical Center

    Greeley, Colorado, 80631

  • Hartford Hospital

    Hartford, Connecticut, 06106

  • Dr. Sudarshan K. Sharma, Ltd.

    Hinsdale, Illinois, 60521

  • Community Health Network

    Indianapolis, Indiana, 46250

  • St Vincent Hospital and Healthcare Center

    Indianapolis, Indiana, 46260

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Kettering Cancer Center

    Kettering, Ohio, 45429

  • University of Tennessee

    Knoxville, Tennessee, 37920

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

    Los Angeles, California, 90048

  • UCLA Women's Health Clinical Research Unit

    Los Angeles, California, 90095

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin, 53792

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of South Alabama Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • The Blavatnik Family-Chelsea Medical Center at Mount Sinai

    New York, New York, 10011

  • Southeastern Regional Medical Center, LLC

    Newnan, Georgia, 30265

  • Stephenson Cancer Center - University of Oklahoma

    Oklahoma City, Oklahoma, 73104

  • UC Irvine Health-Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • AdventHealth Gynecologic Oncology

    Orlando, Florida, 32804

  • Stanford Women's Cancer Center

    Palo Alto, California, 94304

  • The Valley Hospital - Luckow Pavilion

    Paramus, New Jersey, 07652

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • First Health of the Carolinas

    Pinehurst, North Carolina, 28374

  • Magee Women's Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • North Shore Hematology Oncology Assoc. DBA NY Cancer and Blood Specialists

    Port Jefferson Station, New York, 11776

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

  • Women & Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905

  • Center of Hope

    Reno, Nevada, 89511

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Carilion Clinic Gynecology Oncology

    Roanoke, Virginia, 24016

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14620

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • University of California, San Francisco - Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

  • Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System, Inc.

    Savannah, Georgia, 31405

  • Maine Medical Partners - Women's Health - Division of Gynecologic Oncology

    Scarborough, Maine, 04074

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98195

  • Willis-Knighton Physician Network

    Shreveport, Louisiana, 71103

  • Holy Cross Hospital

    Silver Spring, Maryland, 20910

  • Sanford Gynecology Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Dana-Farber/Brigham and Women's Cancer Center in Clinical Affiliation with South Shore Hospital

    South Weymouth, Massachusetts, 02190

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Cox Health

    Springfield, Missouri, 65807

  • Washington University School of Medicine - Division of Gynecologic Oncology

    St Louis, Missouri, 63110

  • Mercy Hospital, David C Pratt Cancer Center

    St Louis, Missouri, 63141

  • Stony Brook University Hospital

    Stony Brook, New York, 11793-7263

  • Olive View UCLA Medical Center

    Sylmar, California, 91342

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

  • Oklahoma Cancer Specialists and Research Institute, LLC

    Tulsa, Oklahoma, 74146

  • Pro Healthcare Waukesha Memorial Hospital

    Waukesha, Wisconsin, 53188

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

  • Abington Memorial Hospital, Hanjani Institute for Gyn Onc

    Willow Grove, Pennsylvania, 19090

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

  • Midwestern Regional Medical Center, LLC

    Zion, Illinois, 60099

Other trials in United States

China14 sites

  • Peking University Cancer Hospital

    Beijing, Haidian District, 100142

  • Hunan Cancer Hospital

    Changsha, Yuelu District, Hunan Province, 410013

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Yuexiu District, Guangdong Province, 510120

  • Sun Yat-sen University Cancer Center

    Guangzhou, Yuexiu District, 510060

  • Qilu Hospital Of Shandong University

    Jinan, Shandong, 200012

  • Nantong Tumor Hospital

    Nantong, Tongzhou District, Jiangsu Province, 226361

  • Fudan University Shanghai Cancer Hospital

    Shanghai, Xuhui District, 201321

  • First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Xinghualing District, Shanxi Province, 030001

  • Tianjin Cancer Hospital

    Tianjin, Hexi District, 300060

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine

    Xi’an, Shanxi, 710061

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Zhejiang, Hangzhou Province, 310009

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Zhejiang, Shangcheng District, Hangzhou Province, 310003

Other trials in China

Spain11 sites

  • VHIO

    Barcelona, 08035

  • Hospital San Pedro de Alcántara

    Cáceres, 10003

  • Hospital Universitario Reina Sofia (Provincial)

    Córdoba, 14004

  • Hospital General Universitario de Elche

    Elche, 03203

  • Institut Catala d'Oncologia

    Girona, 17007

  • ICO

    L'Hospitalet de Llobregat, 08908

  • Clinica Universidad de Navarra

    Madrid, 28027

  • Hospital La Paz

    Madrid, 28046

  • Hospital Son Espases

    Palma de Mallorca, 07120

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • IVO (Instituto Valenciano de Oncología)

    Valencia, 46009

Other trials in Spain

Italy9 sites

  • Policlinico S. Orsola-Malpighi - SSD Oncologia Medica

    Bologna, 40138

  • Ist. di Candiolo - IRCCS Fondazione del Piemonte per l'Oncologia

    Candiolo, 10060

  • Ospedale "Vito Fazzi" - ASL Lecce

    Lecce, 73100

  • SC Oncologia - Ospedale San Luca

    Lucca, 55100

  • IRCCS Ist. Romagnolo per lo studio dei Tumori "Dino Amadori"

    Meldola, 47014

  • IEO - Istituto Europeo di Oncologia

    Milan, 20141

  • IRCCS

    Naples, 80131

  • Nuovo Ospedale Santo Stefano di Prato

    Prato, 59100

  • Fondazione Policlinico "Agostino Gemelli" IRCCS

    Rome, 00168

Other trials in Italy

Belgium8 sites

  • ZNA Middelheim

    Antwerp, 2020

  • AZ St Jan Brugge

    Bruges, 8000

  • UCL St Luc

    Brussels, 1200

  • AZ Maria Middelares

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • CHA Libramont

    Libramont, 6800

  • CHC Liege

    Liège, 4000

  • CHU UCL Namur St. Elisabeth

    Namur, 5000

Other trials in Belgium

Georgia6 sites

  • LTD High Technology Hospital Medcenter

    Batumi, 6000

  • LTD Tbilisi Oncology

    Tbilisi, 0159

  • LTD Aversi Clinic

    Tbilisi, 0160

  • LTD Consilium Medulla - Multiprofile Clinic

    Tbilisi, 0168

  • LTD Caucasus Medical Centre

    Tbilisi, 0186

  • LTD Innova

    Tbilisi, 0186

Other trials in Georgia

Poland5 sites

  • UCK Centrum Medycyny

    Gdansk, 84214

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia, 81519

  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii

    Lodz, 93-513

  • SPSK Nr 2 PUM Klinika Ginekologii Operacyjnej i Onkologii Klinicznej

    Szczecin, 70-111

  • Maria Sklodowska - Curie Instytute Oncolgy Center

    Warsaw, 02-781

Other trials in Poland

United Kingdom5 sites

  • Royal United Hospital Bath NHS Foundation Trust

    Bath, BA1 3NG

  • Clatterbridge Cancer Centre

    Liverpool, L7 8YA

  • The Royal Marsden NHS Foundation Trust (Sutton)

    London, SM2 5PT

  • The Royal Marsden NHS Foundation Trust (Fulham Road)

    London, SW3 6JJ

  • South West Wales Cancer Institute

    Swansea, SA2 8QA

Other trials in United Kingdom

Czechia4 sites

  • Fakul Nemocnice Hradec Kralove

    Hradec Králové, 50005

  • Fakultni Nemocnice Olomouc

    Olomouc, 77900

  • FN Ostrava-Poruba

    Ostrava, 70852

  • UG Prague

    Prague, 12800

Other trials in Czechia

Canada3 sites

  • Clinical Research Unit, Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Sunnybrook Research Institute

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9

Other trials in Canada

France1 site

  • ICANS

    Strasbourg, 67200

Other trials in France

About this study

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)

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.

Being tested
Batiraxcept, Paclitaxel, Placebo
Keywords
Ovarian cancer, Platinum resistant, Recurrent ovarian cancer, High-grade serous adenocarcinoma
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BatiraxceptDrug

    Also called AVB-S6-500

    Batiraxcept is an experimental drug

  • PaclitaxelDrug

    Also called Taxol

    Paclitaxel is the standard of care, background therapy

  • PlaceboOther

    Matching placebo

Study groups in NCT04729608
Study groupRoleWhat they receive
Batiraxcept+PACExperimentalCombination of batiraxcept and PAC
Receives: Drug: Batiraxcept; Drug: Paclitaxel
Placebo+PACPlacebo comparatorPlacebo-controlled arm with PAC
Receives: Drug: Paclitaxel; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

    Measured: 4 months

Secondary outcomes (1)

  1. Overall survival

    Time following the treatment until death

    Measured: 20 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2021
  2. Study start22 Apr 2021
  3. Primary completion4 Aug 2023
  4. Study completion4 Aug 2023

Why it stopped: There were no significant differences in median PFS between batiraxcept + paclitaxel or paclitaxel alone arms. There was no detriment to overall survival. No new safety signals were identified.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04729608
Sponsor's protocol ID
AVB500-OC-004
Other IDs
GOG-3059, ENGOT OV66, AXLerate-OC
Acronym
AXLerate-OC
Status last verified
Oct 2023
First submitted
25 Jan 2021
Last updated
30 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Batiraxcept and Paclitaxel in people with Platinum-resistant Ovarian Cancer, run by Aravive, Inc. at 150 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, China, Spain, Italy, Belgium and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: There were no significant differences in median PFS between batiraxcept + paclitaxel or paclitaxel alone arms. There was no detriment to overall survival. No new safety signals were identified.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04729608.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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