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History of Changes for Study: NCT04729608
Study of AVB-S6-500 in Combination With Paclitaxel vs Paclitaxel in Patients With Platinum-Resistant Recurrent Ovarian Cancer
Latest version (submitted May 3, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 27, 2021 None (earliest Version on record)
2 March 8, 2021 Recruitment Status, Study Status and Contacts/Locations
3 May 3, 2021 Study Status, Contacts/Locations and Study Identification
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Study NCT04729608
Submitted Date:  January 27, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: AVB500-OC-004
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
Secondary IDs: GOG-3059 [GOG Foundation]
Open or close this module Study Status
Record Verification: January 2021
Overall Status: Not yet recruiting
Study Start: February 2021
Primary Completion: July 2023 [Anticipated]
Study Completion: July 2024 [Anticipated]
First Submitted: January 25, 2021
First Submitted that
Met QC Criteria:
January 27, 2021
First Posted: January 28, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
January 27, 2021
Last Update Posted: January 28, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Aravive, Inc.
Responsible Party: Sponsor
Collaborators: GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Platinum-resistant Ovarian Cancer
Keywords: Ovarian cancer
Platinum resistant
Recurrent ovarian cancer
High-grade serous adenocarcinoma
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 500 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: AVB-S6-500+Pac
Combination of AVB-S6-500 and Pac
Drug: AVB-S6-500
AVB-S6-500 is an experimental drug
Drug: Paclitaxel
Paclitaxel is the standard of care, background therapy
Other Names:
  • Taxol
Placebo Comparator: Placebo+Pac
Placebo-controlled arm with Pac
Drug: Paclitaxel
Paclitaxel is the standard of care, background therapy
Other Names:
  • Taxol
Placebo
Matching placebo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
PFS is the time interval between randomization and radiologically documented disease progression or death, whichever comes first.

[Time Frame: 4 months]
Secondary Outcome Measures:
2. Overall survival
Time following the treatment until death

[Time Frame: 20 months]
3. Objective response rate (ORR)
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

[Time Frame: 3 months]
4. Duration of response (DOR)
Measured from the date of partial or complete response to therapy until the cancer progresses based on RECIST v1.1 criteria.

[Time Frame: 9 months]
5. Incidence of Treatment Emergent Adverse Events (TEAEs)
10 months
6. Quality of Life (QOL)
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).

[Time Frame: 10 months]
7. Clinical benefit rate (CBR)
4 months
8. Area under the AVB-S6-500 concentration-time curve.
10 months
9. Maximum observed AVB-S6-500 concentration.
10 months
10. Time of maximum observed AVB-S6-500 concentration.
10 months
11. Half-life of AVB-S6-500.
10 months
12. Pharmacodynamic marker assessment
Change from the baseline in GAS6 serum levels.

[Time Frame: 10 months]
13. Anti-drug antibody (ADA) titers
10 months
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Aravive Clinical Trials
Telephone: 936-355-1910
Email: clinicaltrials@aravive.com
Study Officials: Mary Jo Baker
Study Director
Aravive, Inc.
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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