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

October 26, 2023 updated by: Aravive, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
366

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible.
  • Aged 18 years or older
  • Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1
  • Platinum-resistant disease (defined as progression within ≤6 months from completion of most recent platinum-containing regimen and calculated from the date of the last administered dose of platinum therapy).Subject may have been treated with additional regimen(s) subsequent to determination of platinum resistance.
  • Available archived tumor tissue or if archived tissue is not available, a fresh tumor biopsy.
  • Received at least 1 but not more than 4 prior therapy regimens.

Note: Maintenance therapy OR hormonal therapies should not be counted as a separate therapy.

Note: Patients who have not received prior bevacizumab must be deemed medically inappropriate OR ineligible to receive bevacizumab, refused to receive bevacizumab, or been unable to receive bevacizumab due to lack of access.

  • Measurable disease according to RECIST v1.1 criteria
  • Normal gastrointestinal function.
  • At least 28 days between termination of prior anticancer or hormonal therapy and first administration of batiraxcept.
  • Full recovery from all treatment-related toxicities to Grade 1 or less, except alopecia.

Exclusion Criteria:

  • Tumors in the breast or bone
  • Untreated central nervous system (CNS) metastases. Subjects requiring corticosteroid therapy for the management of their treated CNS metastases may not be on >10 mg/day prednisone or equivalent or have demonstrated signs or symptoms of neurologic instability for 28 days or less prior to randomization.
  • Primary platinum-refractory disease (defined as progression during or within 4 weeks after completion of the first platinum regimen)
  • Is being treated with concurrent anticancer therapy or other interventional treatments administered for their underlying ovarian cancer.
  • Received prior therapy with PAC in the platinum-resistant recurrent setting
  • Evidence of clinically significant third spacing (e.g., pleural effusions, ascites, anasarca, etc.) that requires therapeutic intervention within 28 days prior to first dose of batiraxcept/placebo

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Placebo
Matching placebo
Drug: Paclitaxel
Paclitaxel is the standard of care, background therapy
Other Names:
  • Taxol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
PFS is the time interval between randomization and radiologically documented disease progression or death, whichever comes first.
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 20 months
Time following the treatment until death
20 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of response (DOR)
Time Frame: 9 months
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.
9 months
Objective response rate (ORR)
Time Frame: 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 months
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame: 10 months
10 months
Quality of Life (QOL)
Time Frame: 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).
10 months
Clinical benefit rate (CBR)
Time Frame: 4 months
4 months
Area under the batiraxcept concentration-time curve.
Time Frame: 10 months
10 months
Maximum observed batiraxcept concentration.
Time Frame: 10 months
10 months
Minimum observed batiraxcept concentration.
Time Frame: 10 months
10 months
Pharmacodynamic marker assessment
Time Frame: 10 months
Change from the baseline in GAS6 serum levels.
10 months
Anti-drug antibody (ADA) titers
Time Frame: 10 months
10 months
Cancer antigen 125 (CA-125) levels
Time Frame: 10 months
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aravive, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 4, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 4, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AVB500-OC-004
  • GOG-3059 (Other Identifier: GOG Foundation)
  • ENGOT OV66 (Other Identifier: ENGOT)
  • AXLerate-OC (Other Identifier: Aravive)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

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