18 and older, female only, with Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Patients Who Survive Progression-free for at Least 6 MonthsPrimary· Every other cycle during treatment, then every 3 months until disese progression is confirmed, up to 5 years
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 le
Patients with Progression Free Survival > 6 months
Group
Value
95% CI
Treatment (EGEN-001)
6
Patients with Progression Free Survival < 6 months
Group
Value
95% CI
Treatment (EGEN-001)
14
Patients Who Have Objective Tumor Response (Complete or Partial Response)Primary· 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 years
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.
Group
Value
95% CI
Treatment (EGEN-001)
0.0
0.0 – 13.9
Adverse Events Deemed at Least Possibly Related to Treatment, as Assessed by NCI CTCAE Version 4.0Primary· 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 treatment
Adverse events are listed by adverse event and grade. The number of participants affected is listed.
Ear and labyrinth
Group
Value
95% CI
Grade 0
18
Grade 1 (CTCAE v 4.0)
1
Grade 2 (CTCAE v 4.0)
1
Grade 3 (CTCAE v 4.0)
0
Grade 4 (CTCAE v 4.0)
0
Grade 5 (CTCAE v 4.0)
0
Eye
Group
Value
95% CI
Grade 0
18
Grade 1 (CTCAE v 4.0)
2
Grade 2 (CTCAE v 4.0)
0
Grade 3 (CTCAE v 4.0)
0
Grade 4 (CTCAE v 4.0)
0
Grade 5 (CTCAE v 4.0)
0
Nausea
Group
Value
95% CI
Grade 0
6
Grade 1 (CTCAE v 4.0)
10
Grade 2 (CTCAE v 4.0)
3
Grade 3 (CTCAE v 4.0)
1
Grade 4 (CTCAE v 4.0)
0
Grade 5 (CTCAE v 4.0)
0
Vomiting
Group
Value
95% CI
Grade 0
13
Grade 1 (CTCAE v 4.0)
6
Grade 2 (CTCAE v 4.0)
0
Grade 3 (CTCAE v 4.0)
1
Grade 4 (CTCAE v 4.0)
0
Grade 5 (CTCAE v 4.0)
0
Abdominal pain
Group
Value
95% CI
Grade 0
13
Grade 1 (CTCAE v 4.0)
4
Grade 2 (CTCAE v 4.0)
1
Grade 3 (CTCAE v 4.0)
2
Grade 4 (CTCAE v 4.0)
0
Grade 5 (CTCAE v 4.0)
0
Other GI
Group
Value
95% CI
Grade 0
12
Grade 1 (CTCAE v 4.0)
6
Grade 2 (CTCAE v 4.0)
2
Grade 3 (CTCAE v 4.0)
0
Grade 4 (CTCAE v 4.0)
0
Grade 5 (CTCAE v 4.0)
0
Fever
Group
Value
95% CI
Grade 0
16
Grade 1 (CTCAE v 4.0)
3
Grade 2 (CTCAE v 4.0)
1
Grade 3 (CTCAE v 4.0)
0
Grade 4 (CTCAE v 4.0)
0
Grade 5 (CTCAE v 4.0)
0
Chills
Group
Value
95% CI
Grade 0
16
Grade 1 (CTCAE v 4.0)
4
Grade 2 (CTCAE v 4.0)
0
Grade 3 (CTCAE v 4.0)
0
Grade 4 (CTCAE v 4.0)
0
Grade 5 (CTCAE v 4.0)
0
Overall SurvivalSecondary· The duration of time from start of treatment to time of death or the date of last contact, assessed up to 5 years
The observed length of life from entry into the study to death or the date of last contact.
Group
Value
95% CI
Treatment (EGEN-001)
9.2
5.7 – 16.3
Progression-free SurvivalSecondary· The duration of time from start of treatment to time of progression or death, whichever occurs first, assessed up to 5 years
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.
Group
Value
95% CI
Treatment (EGEN-001)
2.9
2.0 – 6.3
Adverse events — posted to ClinicalTrials.gov
Time frame: 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.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies the side effects and how well EGEN-001 works in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that is persistent or has come back. Biological therapies, such as EGEN-001, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04142398 — Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men
· withdrawn
NCT04142385 — Incidence of HIV Infection in Screening Indian Men Who Have Sex With Men
· withdrawn
NCT05558904 — An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cance
· Phase 1, PHASE2
· recruiting
NCT05564650 — Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome
· Phase 1
· active not recruiting
NCT05396859 — Entrectinib in Combination With ASTX727 for the Treatment of Relapsed/Refractory TP53 Mutated Acute Myeloid Leukemia
· Phase 1
· active not recruiting
Other recruiting trials for Fallopian Tube Carcinoma
Currently open trials in the same condition.
NCT07480954 — Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16)
· Phase 1, PHASE2
· recruiting
NCT07285044 — The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Tr
· Phase 2
· recruiting
NCT06710548 — REVITALIZE: RCT to Reduce Fatigue in Adults With Ovarian Cancer on PARP Inhibitors
· NA
· recruiting
NCT06492070 — Cryocompression With or Without Cilostazol for the Prevention of Paclitaxel-induced Neuropathy in Patients With Gynecolo
· Phase 2
· recruiting
NCT06420973 — RC48 Treatment for Platinum Sensitive Recurrent Ovarian Cancer With HER2 Expression
· Phase 2
· recruiting
Other Gynecologic Oncology Group trials
Trials by the same sponsor.
NCT04393285 — Abemaciclib and Letrozole to Treat Endometrial Cancer
· Phase 2
· active not recruiting
NCT03673124 — Ribociclib and Letrozole Treatment in Ovarian Cancer
· Phase 2
· active not recruiting
NCT02065687 — Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent
· Phase 2, PHASE3
· unknown
NCT01720173 — Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer
· Phase 2
· completed
NCT01406769 — Bioimpedance Spectroscopy in Detecting Lower-Extremity Lymphedema in Patients With Stage I, Stage II, Stage III, or Stag
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Gynecologic Oncology Group
Last refreshed: 11 January 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01118052.