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

  • Interventional
  • Recruiting
  • NCT04729608
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
Female

Age Group
18 Years and up

Accepting 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).

         - 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

At a Glance

National Government IDNCT04729608

IRB#IRB21-0274

Lead SponsorAravive, Inc.

Lead PhysicianKathryn Mills

Collaborator(s)N/A

EligibilityFemale
18 Years and up
Recruiting