Clinical Trials /

Study of AVB-S6-500 in Combination With Paclitaxel vs Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer

NCT04729608

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.

Related Conditions:
  • High Grade Fallopian Tube Serous Adenocarcinoma
  • High Grade Ovarian Serous Adenocarcinoma
  • Primary Peritoneal High Grade Serous Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

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

DrugSynonymsArms
AVB-S6-500AVB-S6-500+Pac
PaclitaxelTaxolAVB-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

NameTypeDescriptionInterventions
AVB-S6-500+PacExperimentalCombination of AVB-S6-500 and Pac
  • AVB-S6-500
  • Paclitaxel
Placebo+PacPlacebo ComparatorPlacebo-controlled arm with Pac
  • Paclitaxel

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

May 20, 2021