Platinum-resistant Ovarian Cancer
Conditions
Keywords
Ovarian cancer, Platinum resistant, Recurrent ovarian cancer, High-grade serous adenocarcinoma
Brief 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.
Interventions
DRUGBatiraxcept
Batiraxcept is an experimental drug
DRUGPaclitaxel
Paclitaxel is the standard of care, background therapy
OTHERPlacebo
Matching placebo
Sponsors
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Aravive, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 batiraxcept. * 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 batiraxcept/placebo
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-tumor activity of batiraxcept in combination with PAC measured by progression free survival (PFS) in patients receiving batiraxcept + PAC versus patients receiving Placebo+PAC | 4 months | PFS is the time interval between randomization and radiologically documented disease progression or death, whichever comes first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 20 months | Time following the treatment until death |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DOR) | 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) | 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) | 10 months | — |
| Quality of Life (QOL) | 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). |
| Anti-drug antibody (ADA) titers | 10 months | — |
| Area under the batiraxcept concentration-time curve. | 10 months | — |
| Maximum observed batiraxcept concentration. | 10 months | — |
| Minimum observed batiraxcept concentration. | 10 months | — |
| Pharmacodynamic marker assessment | 10 months | Change from the baseline in GAS6 serum levels. |
| Clinical benefit rate (CBR) | 4 months | — |
| Cancer antigen 125 (CA-125) levels | 10 months | — |
Countries
Belgium, Canada, China, Czechia, France, Georgia, Italy, Poland, Spain, United Kingdom, United States
Outcome results
None listed