Description:
This is a Phase 3 study of AVB-S6-500 in combination with paclitaxel (Pac) in patients with
platinum resistant recurrent ovarian cancer. This is a randomized, double-blind,
placebo-controlled study to compare efficacy and tolerability of AVB-S6-500 in combination
with Pac versus placebo plus Pac.
Title
- Brief Title: Study of AVB-S6-500 in Combination With Paclitaxel vs Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer
- Official Title: A Phase 3, Randomized, Double-Blind, Adaptive, Placebo/Paclitaxel-Controlled Study of AVB-S6-500 in Combination With Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer
Clinical Trial IDs
- ORG STUDY ID:
AVB500-OC-004
- SECONDARY ID:
GOG-3059
- SECONDARY ID:
ENGOT OV66
- NCT ID:
NCT04729608
Conditions
- Platinum-resistant Ovarian Cancer
Interventions
Drug | Synonyms | Arms |
---|
AVB-S6-500 | | AVB-S6-500+Pac |
Paclitaxel | Taxol | AVB-S6-500+Pac |
Purpose
This is a Phase 3 study of AVB-S6-500 in combination with paclitaxel (Pac) in patients with
platinum resistant recurrent ovarian cancer. This is a randomized, double-blind,
placebo-controlled study to compare efficacy and tolerability of AVB-S6-500 in combination
with Pac versus placebo plus Pac.
Trial Arms
Name | Type | Description | Interventions |
---|
AVB-S6-500+Pac | Experimental | Combination of AVB-S6-500 and Pac | |
Placebo+Pac | Placebo Comparator | Placebo-controlled arm with Pac | |
Eligibility Criteria
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).
- 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.
- Measurable disease according to RECIST v1.1 criteria
Exclusion Criteria:
- Tumors in the breast or bone
- Untreated central nervous system (CNS) metastases (surgery and/or radiotherapy).
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 recurrent setting
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Anti-tumor activity of AVB-S6-500 in combination with Pac measured by progression free survival (PFS) in patients receiving AVB-S6-500+ Pac versus patients receiving Placebo+Pac |
Time Frame: | 4 months |
Safety Issue: | |
Description: | PFS is the time interval between randomization and radiologically documented disease progression or death, whichever comes first. |
Secondary Outcome Measures
Measure: | Overall survival |
Time Frame: | 20 months |
Safety Issue: | |
Description: | Time following the treatment until death |
Measure: | Objective response rate (ORR) |
Time Frame: | 3 months |
Safety Issue: | |
Description: | 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 |
Measure: | Duration of response (DOR) |
Time Frame: | 9 months |
Safety Issue: | |
Description: | Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria. |
Measure: | Incidence of Treatment Emergent Adverse Events (TEAEs) |
Time Frame: | 10 months |
Safety Issue: | |
Description: | |
Measure: | Quality of Life (QOL) |
Time Frame: | 10 months |
Safety Issue: | |
Description: | 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). |
Measure: | Clinical benefit rate (CBR) |
Time Frame: | 4 months |
Safety Issue: | |
Description: | |
Measure: | Area under the AVB-S6-500 concentration-time curve. |
Time Frame: | 10 months |
Safety Issue: | |
Description: | |
Measure: | Maximum observed AVB-S6-500 concentration. |
Time Frame: | 10 months |
Safety Issue: | |
Description: | |
Measure: | Time of maximum observed AVB-S6-500 concentration. |
Time Frame: | 10 months |
Safety Issue: | |
Description: | |
Measure: | Half-life of AVB-S6-500. |
Time Frame: | 10 months |
Safety Issue: | |
Description: | |
Measure: | Pharmacodynamic marker assessment |
Time Frame: | 10 months |
Safety Issue: | |
Description: | Change from the baseline in GAS6 serum levels. |
Measure: | Anti-drug antibody (ADA) titers |
Time Frame: | 10 months |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Aravive, Inc. |
Trial Keywords
- Ovarian cancer
- Platinum resistant
- Recurrent ovarian cancer
- High-grade serous adenocarcinoma
Last Updated
August 18, 2021