Phase II Study of Intraperitoneal NanoPac® in Patients With Ovarian Cancer
Stopped early · Phase 2
Conditions studied: Ovarian Carcinoma
In brief
This study will evaluate NanoPac® administered intraperitoneally (IP) immediately post-cytoreductive surgery, followed by standard of care (SOC) intravenous (IV) chemotherapy, in women with ovarian cancer. The study will compare IP NanoPac® (plus IV chemotherapy) with SOC IV chemotherapy alone.
Key facts
- Study ID
- NCT03029585
- Run by
- NanOlogy, LLC
- People needed
- 10
- Starts
- 2017-04-19
- Expected to finish
- 2019-11-04
- Last updated by the study team
- 2021-04-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Epithelial ovarian cancer which is contained within the abdomen, but may include pleural effusion if that is the limit of non-peritoneal cavity disease. If subject has recurrent epithelial ovarian cancer, the disease must be platinum sensitive (recurrence >6 months from prior chemotherapy regimen that included a platinum agent and cytoreductive surgery)
- Subject appropriate for cytoreductive surgery and treatment with IV platinum and paclitaxel
- Minimal or non-symptomatic ascites
- ≥18 years old
- Signed informed consent
You may not qualify if…
- Epithelial ovarian cancer outside of the peritoneal cavity, with the exception of pleural effusions
- Anticipated use of concomitant chemotherapy (other than the protocol-specified agents), immunotherapy, or radiation therapy
- Treatment with a prior investigational agent within 30 days of planned instillation of NanoPac®, with the exception of subjects participating in poly (ADP-ribose) polymerase (PARP) inhibitor trials. These subjects must discontinue the investigational agent prior to surgery
- Known sensitivity to any of the study medication components or the chemotherapy regimen
- History of prior malignancy other than ovarian that has not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma or cervical carcinoma in situ on biopsy
- Ileostomy or hepatic resection during current cytoreductive surgery
- Women of childbearing potential not practicing adequate forms of birth control
Where it is running
- University of Chicago — Chicago, Illinois, United States
- Greater Baltimore Medical Center — Baltimore, Maryland, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- SUNY Downstate — Brooklyn, New York, United States
- Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
- Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
- University of Texas Southwestern — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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