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

  • End date
    Jul 13, 2024
  • participants needed
  • sponsor
    Aravive, Inc.
Updated on 4 October 2022


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 Platinum-resistant Ovarian Cancer
Treatment Placebo, Paclitaxel, AVB-S6-500, batiraxcept
Clinical Study IdentifierNCT04729608
SponsorAravive, Inc.
Last Modified on4 October 2022


Yes No Not Sure

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
Measurable disease according to RECIST v1.1 criteria
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
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

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
Received prior therapy with PAC in the platinum-resistant recurrent setting
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
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note