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

Status
Active
Cancer Type
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Female
Study Type
Treatment
NCT ID
NCT04729608
Protocol IDs
AVB500-OC-004 (primary)
GOG-3059
NCI-2021-05984
AXLerate-OC
ENGOT OV66
Study Sponsor
Aravive, Inc.

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.

Eligibility

  1. Histologically confirmed and documented recurrent ovarian, fallopian tube, or peritoneal cancer. Only patients with high-grade serous adenocarcinoma histology are eligible.
  2. Aged 18 years or older
  3. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1
  4. 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.
  5. Available archived tumor tissue or if archived tissue is not available, a fresh tumor biopsy.
  6. 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.
  7. Measurable disease according to RECIST v1.1 criteria
  8. Normal gastrointestinal function.
  9. At least 28 days between termination of prior anticancer or hormonal therapy and first administration of batiraxcept.
  10. Full recovery from all treatment-related toxicities to Grade 1 or less, except alopecia.

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Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.