GOG-3059

  • STATUS
    Recruiting
Updated on 29 July 2021
paclitaxel
measurable disease
hormone therapy
fallopian tube
peritoneal cancer
recurrent ovarian cancer
cancer of the ovary

Summary

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.

Details
Condition Ovarian Cancer
Clinical Study IdentifierTX277863
Last Modified on29 July 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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