Trial Outcomes & Findings for Efficacy of Plasmid Elenagen in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer (NCT NCT05979298)

Last Updated: 2026-08-24

Results Overview

Median duration of time from start of treatment to time of progression by RESIST 1.1 criterion or death. Progression is defined using RECIST v 1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

2 years since the start of treatment

Results posted on

2026-08-24

Participant Flow

All patients were recruited in medical clinics of Republic of Belarus,

Participant milestones

Participant milestones
Measure	Gemcitabin Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks	Gemcitabine+Elenagen GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly)
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Plasmid Elenagen in Combination With Gemcitabine in Patients With Platinum-resistant Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gemcitabin n=20 Participants Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks	Gemcitabine+Elenagen n=20 Participants GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly)	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1541 Participants	0 Participants n=1121 Participants	0 Participants n=2662 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=1541 Participants	20 Participants n=1121 Participants	40 Participants n=2662 Participants
Age, Categorical >=65 years	0 Participants n=1541 Participants	0 Participants n=1121 Participants	0 Participants n=2662 Participants
Sex: Female, Male Female	20 Participants n=1541 Participants	20 Participants n=1121 Participants	40 Participants n=2662 Participants
Sex: Female, Male Male	0 Participants n=1541 Participants	0 Participants n=1121 Participants	0 Participants n=2662 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=1541 Participants	0 Participants n=1121 Participants	0 Participants n=2662 Participants
Race (NIH/OMB) Asian	0 Participants n=1541 Participants	0 Participants n=1121 Participants	0 Participants n=2662 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1541 Participants	0 Participants n=1121 Participants	0 Participants n=2662 Participants
Race (NIH/OMB) Black or African American	0 Participants n=1541 Participants	0 Participants n=1121 Participants	0 Participants n=2662 Participants
Race (NIH/OMB) White	20 Participants n=1541 Participants	20 Participants n=1121 Participants	40 Participants n=2662 Participants
Race (NIH/OMB) More than one race	0 Participants n=1541 Participants	0 Participants n=1121 Participants	0 Participants n=2662 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=1541 Participants	0 Participants n=1121 Participants	0 Participants n=2662 Participants
Region of Enrollment Belarus	20 Participants n=1541 Participants	20 Participants n=1121 Participants	40 Participants n=2662 Participants
CA125 oncomarker	132 units per ml n=1541 Participants	101 units per ml n=1121 Participants	116 units per ml n=2662 Participants

PRIMARY outcome

Timeframe: 2 years since the start of treatment

Outcome measures

Outcome measures
Measure	Gemcitabin n=20 Participants Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks	Gemcitabine+Elenagen n=20 Participants GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly)
Progression-free Survival (PFS)	2.8 Months Interval 2.1 to 7.7	7.2 Months Interval 4.2 to Not reached due to an insufficient number of participants with a progression event

SECONDARY outcome

Timeframe: 1 year after the start of treatment

Frequency of drug-related adverse events (AEs) and serious AEs (SAEs) according to NCI CTCAE version 5.0.

Outcome measures

Outcome measures
Measure	Gemcitabin n=20 Participants Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks	Gemcitabine+Elenagen n=20 Participants GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly)
Safety of Elenagen in Combination With Gemcitabine	20 Participants	20 Participants

Adverse Events

Gemcitabin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Gemcitabine+Elenagen

Serious events: 0 serious events

Other events: 7 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Gemcitabin n=20 participants at risk Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks	Gemcitabine+Elenagen n=20 participants at risk GEM was supplemented with ELENAGEN (2.5 mg i.m. weekly)
Blood and lymphatic system disorders Neutropenia	20.0% 4/20 • From enrolment until end of follow-up, up to 24 months In the safety analysis set and in the efficacy-evaluable set, all patients who received ≥ 1 dose (20 patients in each arm) were included. Safety was assessed on the basis of adverse events (AEs) and serious AEs (SAEs) according to NCI Common Terminology Criteria for Adverse Events version 5.0.	35.0% 7/20 • From enrolment until end of follow-up, up to 24 months In the safety analysis set and in the efficacy-evaluable set, all patients who received ≥ 1 dose (20 patients in each arm) were included. Safety was assessed on the basis of adverse events (AEs) and serious AEs (SAEs) according to NCI Common Terminology Criteria for Adverse Events version 5.0.

Additional Information

Vladimir Gabai, PhD

CureLab Oncology

Phone: +1 (617)319-7314

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place