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

  • STATUS
    Recruiting
  • End date
    Jul 3, 2024
  • participants needed
    400
  • sponsor
    Aravive, Inc.
Updated on 5 December 2021

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.

Details
Condition Platinum Resistant Ovarian Cancer
Treatment Placebo, Paclitaxel, AVB-S6-500, batiraxcept
Clinical Study IdentifierNCT04729608
SponsorAravive, Inc.
Last Modified on5 December 2021

Eligibility

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
Measurable disease according to RECIST v1.1 criteria
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
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
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
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
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
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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.

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