Trial Outcomes & Findings for EGEN-001 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer (NCT NCT01118052)
NCT ID: NCT01118052
Last Updated: 2018-01-11
Results Overview
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Every other cycle during treatment, then every 3 months until disese progression is confirmed, up to 5 years
Results posted on
2018-01-11
Participant Flow
GOG 170Q accrued 22 patients from November 2010 to January 2013.
Participant milestones
| Measure |
Treatment (EGEN-001)
Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (EGEN-001)
Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally
|
|---|---|
|
Overall Study
Never treated
|
2
|
Baseline Characteristics
EGEN-001 in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Treatment (EGEN-001)
n=20 Participants
Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally
|
|---|---|
|
Age, Customized
< 40 years
|
0 Participants
n=99 Participants
|
|
Age, Customized
40 - 49 years
|
1 Participants
n=99 Participants
|
|
Age, Customized
50 - 59 years
|
12 Participants
n=99 Participants
|
|
Age, Customized
60 - 69 years
|
5 Participants
n=99 Participants
|
|
Age, Customized
70 - 79 years
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Every other cycle during treatment, then every 3 months until disese progression is confirmed, up to 5 yearsPopulation: Eligible and treated patients
Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression was based on RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression
Outcome measures
| Measure |
Treatment (EGEN-001)
n=20 Participants
Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally
|
Grade 1 (CTCAE v 4.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v 4.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
|
Grade 3 (CTCAE v 4.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
|
Grade 4 (CTCAE v 4.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
|
Grade 5 (CTCAE v 4.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
|
|---|---|---|---|---|---|---|
|
Patients Who Survive Progression-free for at Least 6 Months
Patients with Progression Free Survival > 6 months
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Patients Who Survive Progression-free for at Least 6 Months
Patients with Progression Free Survival < 6 months
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: CT or MRI used to follow lesion for measurable disease every other cycle. Patient's best response while on study treatment was recorded, Up to 5 yearsPopulation: Eligible and Treated patients
Complete and Partial Tumor Response by RECIST 1.1. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Treatment (EGEN-001)
n=20 Participants
Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally
|
Grade 1 (CTCAE v 4.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v 4.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
|
Grade 3 (CTCAE v 4.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
|
Grade 4 (CTCAE v 4.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
|
Grade 5 (CTCAE v 4.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
|
|---|---|---|---|---|---|---|
|
Patients Who Have Objective Tumor Response (Complete or Partial Response)
|
0.0 percentage of participants
Interval 0.0 to 13.9
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: All Adverse Events (AEs) deemed at least possibly related to study treatmetn occurring during treatment and up to 30 days after stopping the study treatment. for up to 5 years after stopping study treatmentPopulation: Eligible and evaluable patients
Adverse events are listed by adverse event and grade. The number of participants affected is listed.
Outcome measures
| Measure |
Treatment (EGEN-001)
n=20 Participants
Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally
|
Grade 1 (CTCAE v 4.0)
n=20 Participants
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v 4.0)
n=20 Participants
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
|
Grade 3 (CTCAE v 4.0)
n=20 Participants
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
|
Grade 4 (CTCAE v 4.0)
n=20 Participants
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
|
Grade 5 (CTCAE v 4.0)
n=20 Participants
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
|
|---|---|---|---|---|---|---|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Anorexia
|
17 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Dehydration
|
18 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Musculoskeletal/connective tissue
|
17 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Peripheral Sensory neuropathy
|
17 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Other nervous system
|
17 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Psychiatric
|
17 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Reproductive/breast
|
19 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Respiratory/thoracic/mediastinal
|
18 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Skin/subcutaneous
|
16 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Leukopenia
|
15 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Lymphopenia
|
18 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Ear and labyrinth
|
18 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Eye
|
18 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Nausea
|
6 Participants
|
10 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Vomiting
|
13 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Abdominal pain
|
13 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Other GI
|
12 Participants
|
6 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Fever
|
16 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Chills
|
16 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Fatigue
|
9 Participants
|
7 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
General, NOS
|
15 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Administrative site
|
17 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Infections/infestations
|
19 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Neutropenia
|
15 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Thrombocytopenia
|
13 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Anemia
|
9 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Hyponatremia
|
19 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Elevated Creatinine
|
18 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Hyperglycemia
|
19 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Hypomagnesemia
|
18 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Hypoalbuminemia
|
19 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Elevated alanine aminotransferase
|
19 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Elevated alkaline phosphatase
|
18 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Elevated aspartate aminotransferase
|
18 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Elevated GGT
|
19 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0
Elevated bilirubin
|
19 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: The duration of time from start of treatment to time of death or the date of last contact, assessed up to 5 yearsPopulation: Eligible and treated patients
The observed length of life from entry into the study to death or the date of last contact.
Outcome measures
| Measure |
Treatment (EGEN-001)
n=20 Participants
Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally
|
Grade 1 (CTCAE v 4.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v 4.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
|
Grade 3 (CTCAE v 4.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
|
Grade 4 (CTCAE v 4.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
|
Grade 5 (CTCAE v 4.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
|
|---|---|---|---|---|---|---|
|
Overall Survival
|
9.2 months
Interval 5.7 to 16.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 yearsPopulation: Eligible and treated patients
The time from entry until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored.
Outcome measures
| Measure |
Treatment (EGEN-001)
n=20 Participants
Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally
|
Grade 1 (CTCAE v 4.0)
Number of patients who experienced a grade 1 event using Common Terminology Criteria version 4.0
|
Grade 2 (CTCAE v 4.0)
Number of patients who experienced a grade 2 event using Common Terminology Criteria version 4.0
|
Grade 3 (CTCAE v 4.0)
Number of patients who experienced a grade 3 event using Common Terminology Criteria version 4.0
|
Grade 4 (CTCAE v 4.0)
Number of patients who experienced a grade 4 event using Common Terminology Criteria version 4.0
|
Grade 5 (CTCAE v 4.0)
Number of patients who experienced a grade 5 event using Common Terminology Criteria version 4.0
|
|---|---|---|---|---|---|---|
|
Progression-free Survival
|
2.9 months
Interval 2.0 to 6.3
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Treatment (EGEN-001)
Serious events: 9 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (EGEN-001)
n=20 participants at risk
Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Colonic Obstruction
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
15.0%
3/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Ileal Fistula
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Death Nos
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Injury, poisoning and procedural complications
Fracture
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Investigations
Creatinine Increased
|
15.0%
3/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Investigations
White Blood Cell Decreased
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
Other adverse events
| Measure |
Treatment (EGEN-001)
n=20 participants at risk
Patients receive intraperitoneal EGEN-001 on days 1, 8, 15, and 22. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1: Given intraperitoneally
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
75.0%
15/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Ear and labyrinth disorders
Hearing Impaired
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Ear and labyrinth disorders
Ear Pain
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Endocrine disorders
Hyperthyroidism
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Eye disorders
Blurred Vision
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Constipation
|
45.0%
9/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Diarrhea
|
45.0%
9/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
8/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Bloating
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Anal Hemorrhage
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Abdominal Pain
|
45.0%
9/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Rectal Hemorrhage
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Abdominal Distension
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Nausea
|
75.0%
15/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Pain
|
30.0%
6/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Malaise
|
15.0%
3/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Injection Site Reaction
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Infusion Site Extravasation
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Flu Like Symptoms
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Fatigue
|
65.0%
13/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Fever
|
20.0%
4/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
General disorders
Chills
|
20.0%
4/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Infections and infestations
Urinary Tract Infection
|
20.0%
4/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Injury, poisoning and procedural complications
Fall
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Investigations
Weight Loss
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Investigations
Platelet Count Decreased
|
35.0%
7/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Investigations
Lymphocyte Count Decreased
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Investigations
Ggt Increased
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Investigations
Creatinine Increased
|
30.0%
6/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Investigations
Neutrophil Count Decreased
|
25.0%
5/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Investigations
Blood Bilirubin Increased
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Investigations
White Blood Cell Decreased
|
25.0%
5/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Investigations
Aspartate Aminotransferase Increased
|
15.0%
3/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Investigations
Alkaline Phosphatase Increased
|
20.0%
4/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Investigations
Alanine Aminotransferase Increased
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
25.0%
5/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
25.0%
5/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
25.0%
5/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
5/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.0%
4/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
20.0%
4/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Memory Impairment
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Lethargy
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Syncope
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Nervous system disorders
Depressed Level Of Consciousness
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Psychiatric disorders
Insomnia
|
25.0%
5/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Urinary Frequency
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Renal and urinary disorders
Bladder Spasm
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Reproductive system and breast disorders
Vaginal Pain
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.0%
3/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders - Other
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Nail Ridging
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Skin and subcutaneous tissue disorders
Bullous Dermatitis
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Reproductive system and breast disorders
Menopause
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Vascular disorders
Thromboembolic Event
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
|
Vascular disorders
Hot Flashes
|
5.0%
1/20 • All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60