Phase II, two arm prospective study of efficacy and safety of ELENAGEN in combination with gemcitabine in comparison with gemcitabine alone in patients with platinum-resistant ovarian cancer.
The purpose of this clinical study is to evaluate safety and efficacy of ELENAGEN, a novel anticancer therapeutics (plasmid DNA encoding p62/SQSTM1) protein, as an adjuvant to chemotherapy with Gemcitabin (GEM) in patients with advanced platinum-resistant ovarian cancer. This is a prospective randomized multi-center study with two arms. Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks) is administered in both arms: In the Chemo arm (n = 20) Gemcitabine is the only treatment, and in the ELENAGEN arm (n = 20) GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly). The primary endpoint is progression-free survival (PFS), and the secondary endpoint is safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Chemotherapeutics
DNA plasmid
Minsk City Clinical Oncology Center
Minsk, Belarus
Progression-free survival (PFS)
Median duration of time from start of treatment to time of progression by RESIST 1.1 criterion or death
Time frame: 2 years since the start of treatment
Safety of Elenagen in combination with Gemcitabine
Frequency of drug-related adverse events (AEs) and serious AEs (SAEs) according to NCI CTCAE version 5.0.
Time frame: 1 year after the start of treatment
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