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PhIII AVB-56-500 in Combo w/Paclitaxel in Pts w/Platinum-Resistant Recur Ovarian Ca

Fabio Cappuccini


A Study On:

  • Ovary

Status:

  • Open

Eligibility

18 Years and older (Adult, Older Adult)
Female

Interested in joining this trial?

Official Title

A Phase III, Randomized, Double-Blind, Adaptive, Placebo/Paclitaxel-Controlled Study of AVB-56-500 in Combination with Paclitaxel in Patients with Platinum-Resistant Recurrent Ovarian Cancer

Details

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.


Eligibility

You can join if...

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
-Platinum-resistant disease (defined as progression within < or = to 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

Get in touch with our study team