Clinical trial · Interventional
Phase II Study of Intraperitoneal NanoPac® in Patients With Ovarian Cancer
Phase II Study of Four Dose Levels of Intraperitoneal NanoPac® Plus IV Carboplatin and Paclitaxel in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery
NCT03029585CI-TRIAL-00051475terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business reasons
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Carcinoma | Ovarian Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NanoPac® 100 mg/m2 | Drug | — | UNRESOLVED |
| NanoPac® 200 mg/m2 | Drug | — | UNRESOLVED |
| NanoPac® 300 mg/m2 | Drug | — | UNRESOLVED |
| NanoPac® 400 mg/m2 | Drug | — | UNRESOLVED |
| Standard of Care Intravenous Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- NanoPac® 100 mg/m2
- description
- Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
- interventionNames
- Drug: NanoPac® 100 mg/m2
- Drug: Standard of Care Intravenous Chemotherapy
- type
- EXPERIMENTAL
- label
- NanoPac® 200 mg/m2
- description
- Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
- interventionNames
- Drug: NanoPac® 200 mg/m2
- Drug: Standard of Care Intravenous Chemotherapy
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.