Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04729608
Recruitment Status : Recruiting
First Posted : January 28, 2021
Last Update Posted : May 10, 2022
Sponsor:
Collaborators:
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Information provided by (Responsible Party):
Aravive, Inc.

Tracking Information
First Submitted Date  ICMJE January 25, 2021
First Posted Date  ICMJE January 28, 2021
Last Update Posted Date May 10, 2022
Actual Study Start Date  ICMJE April 22, 2021
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2021)
Anti-tumor activity of AVB-S6-500 in combination with Pac measured by progression free survival (PFS) in patients receiving AVB-S6-500 + 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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 27, 2021)
Anti-tumor activity of AVB-S6-500 in combination with Pac measured by progression free survival (PFS) in patients receiving AVB-S6-500+ 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2021)
Overall survival [ Time Frame: 20 months ]
Time following the treatment until death
Original Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2021)
  • Overall survival [ Time Frame: 20 months ]
    Time following the treatment until death
  • 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
  • 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.
  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 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).
  • Clinical benefit rate (CBR) [ Time Frame: 4 months ]
  • Area under the AVB-S6-500 concentration-time curve. [ Time Frame: 10 months ]
  • Maximum observed AVB-S6-500 concentration. [ Time Frame: 10 months ]
  • Time of maximum observed AVB-S6-500 concentration. [ Time Frame: 10 months ]
  • Half-life of AVB-S6-500. [ Time Frame: 10 months ]
  • Pharmacodynamic marker assessment [ Time Frame: 10 months ]
    Change from the baseline in GAS6 serum levels.
  • Anti-drug antibody (ADA) titers [ Time Frame: 10 months ]
Current Other Pre-specified Outcome Measures
 (submitted: September 22, 2021)
  • 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.
  • 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
  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 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).
  • Clinical benefit rate (CBR) [ Time Frame: 4 months ]
  • Area under the AVB-S6-500 concentration-time curve. [ Time Frame: 10 months ]
  • Maximum observed AVB-S6-500 concentration. [ Time Frame: 10 months ]
  • Minimum observed AVB-S6-500 concentration. [ Time Frame: 10 months ]
  • Pharmacodynamic marker assessment [ Time Frame: 10 months ]
    Change from the baseline in GAS6 serum levels.
  • Anti-drug antibody (ADA) titers [ Time Frame: 10 months ]
  • Cancer antigen 125 (CA-125) levels [ Time Frame: 10 months ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AVB-S6-500 (Batiraxcept)/Placebo in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Adaptive, Placebo/Paclitaxel-Controlled Study of AVB-S6-500 in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer (AXLerate-OC)
Brief Summary This is a randomize, double-blind Phase 3 study to compare the efficacy and safety of AVB-S6-500 in combination with paclitaxel (Pac) versus placebo in combination with Pac in patients with platinum resistant recurrent ovarian cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Platinum-resistant Ovarian Cancer
Intervention  ICMJE
  • Drug: Batiraxcept
    Batiraxcept is an experimental drug
    Other Name: AVB-S6-500
  • Drug: Paclitaxel
    Paclitaxel is the standard of care, background therapy
    Other Name: Taxol
  • Other: Placebo
    Matching placebo
Study Arms  ICMJE
  • Experimental: Batiraxcept+Pac
    Combination of batiraxcept and Pac
    Interventions:
    • Drug: Batiraxcept
    • Drug: Paclitaxel
  • Placebo Comparator: Placebo+Pac
    Placebo-controlled arm with Pac
    Interventions:
    • Drug: Paclitaxel
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 22, 2021)
400
Original Estimated Enrollment  ICMJE
 (submitted: January 27, 2021)
500
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 AVB-S6-500.
  • 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 AVB-S6-500/placebo
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Aravive Clinical Trials 936-355-1910 clinicaltrials@aravive.com
Listed Location Countries  ICMJE Belgium,   Canada,   China,   Czechia,   France,   Italy,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04729608
Other Study ID Numbers  ICMJE AVB500-OC-004
GOG-3059 ( Other Identifier: GOG Foundation )
ENGOT OV66 ( Other Identifier: ENGOT )
AXLerate-OC ( Other Identifier: Aravive )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aravive, Inc.
Study Sponsor  ICMJE Aravive, Inc.
Collaborators  ICMJE
  • GOG Foundation
  • European Network of Gynaecological Oncological Trial Groups (ENGOT)
Investigators  ICMJE
Study Director: Reshma Rangwala, MD Aravive, Inc.
PRS Account Aravive, Inc.
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP