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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

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.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this study is to determine 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.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who meet this 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

Excluding patients who meet this 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
     

Accepting new patients

 

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