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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Platinum-resistant Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT04729608

Run by

Aravive, Inc.

People needed

366

Starts

2021-04-22

Expected to finish

2023-08-04

Last updated by the study team

2023-10-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Disney Family Cancer Center — Burbank, California, United States
• Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute — Los Angeles, California, United States
• UCLA Women's Health Clinical Research Unit — Los Angeles, California, United States
• UC Irvine Health-Chao Family Comprehensive Cancer Center — Orange, California, United States
• Stanford Women's Cancer Center — Palo Alto, California, United States
• University of California, San Francisco - Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Olive View UCLA Medical Center — Sylmar, California, United States
• Banner MD Anderson Cancer Center/North Colorado Medical Center — Greeley, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• AdventHealth Gynecologic Oncology — Orlando, Florida, United States
• Florida Cancer Specialists — West Palm Beach, Florida, United States
• Georgia Cancer Center at Augusta University — Augusta, Georgia, United States
• Northeast Georgia Medical Center — Gainesville, Georgia, United States
• Southeastern Regional Medical Center, LLC — Newnan, Georgia, United States
• Lewis Cancer & Research Pavilion at St. Joseph's/Candler Health System, Inc. — Savannah, Georgia, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• North Shore University Health System — Evanston, Illinois, United States
• Dr. Sudarshan K. Sharma, Ltd. — Hinsdale, Illinois, United States
• Midwestern Regional Medical Center, LLC — Zion, Illinois, United States
• Community Health Network — Indianapolis, Indiana, United States
• St Vincent Hospital and Healthcare Center — Indianapolis, Indiana, United States
• University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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