Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03029585

Phase II Study of Intraperitoneal NanoPac® in Patients With Ovarian Cancer

Ovarian Carcinoma Clinical Trial

Official title:
Phase II Study of Four Dose Levels of Intraperitoneal NanoPac® Plus IV Carboplatin and Paclitaxel in Patients With Epithelial Ovarian Cancer Undergoing Cytoreductive Surgery

Clinical Trial Summary

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.

Clinical Trial Description

Research has shown that the administration of chemotherapy directly into the peritoneal cavity (intraperitoneal [IP] chemotherapy) may provide a significant survival benefit to women with ovarian cancer when combined with cytoreductive surgery and IV chemotherapy. This study will include a dose-finding phase and an efficacy phase to evaluate IP NanoPac® administered immediately post-cytoreductive surgery in women with ovarian cancer. In the dose-finding phase, subjects will be enrolled in dose-escalated cohorts of three subjects and receive IP NanoPac® at 100, 200, 300, or 400 mg/m2 plus standard of care (SOC) IV chemotherapy. Subjects will be followed for disease status for 12 months. The two best doses from the dose-finding phase will be determined. In the efficacy phase, subjects will be randomized 1:1:1 to one of the two best doses plus SOC IV chemotherapy or SOC alone. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03029585
Study type Interventional
Source NanOlogy, LLC
Contact
Status Terminated
Phase Phase 2
Start date April 19, 2017
Completion date November 4, 2019
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05494580 - Pamiparib Plus Surufatinib in Patients With Platinum-resistant Ovarian Cancer Phase 1/Phase 2
Withdrawn NCT02530606 - Photoacoustic Imaging in Detecting Ovarian or Fallopian Tube Cancer N/A
Active, not recruiting NCT02244502 - Safety, Feasibility and Effect of TTFields (200 kHz) Concomitant With Weekly Paclitaxel in Recurrent Ovarian Carcinoma (INNOVATE) Phase 1/Phase 2
Terminated NCT02218502 - Study Into a New Diagnostic Tool (Simple Ultrasound-based Rules) in Patients With Adnexal Masses N/A
Terminated NCT01936974 - (PGA) for Platinum-resistant/Refractory, Paclitaxel-Pretreated Recurrent Ovarian and Peritoneal Carcinoma Phase 2
Recruiting NCT02073500 - Peritoneal Surface Malignancies - Characterization, Models and Treatment Strategies
Completed NCT00756847 - Safety Study of XL147 (SAR245408), in Combination With Paclitaxel and Carboplatin in Adults With Solid Tumors Phase 1
Withdrawn NCT02878980 - An Exercise Intervention Trial to Reduce Symptoms & Improve Clinical Outcomes of Platinum-Based Treatment in Ovarian Cancer Patients N/A
Active, not recruiting NCT02194387 - Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members N/A
Recruiting NCT05001282 - A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRĪ±) Phase 1/Phase 2
Recruiting NCT04251052 - A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer N/A
Recruiting NCT04981119 - Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Completed NCT00989651 - Carboplatin, Paclitaxel, Bevacizumab, and Veliparib in Treating Patients With Newly Diagnosed Stage II-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Phase 1
Not yet recruiting NCT05591560 - Itraconazole in Advanced Ovarian Cancer N/A
Completed NCT01481701 - A Trial Evaluating Efficacy and Safety of Oxaliplatin With 5-Fluorouracil in Patients With Recurrent Ovarian Carcinoma Phase 2
Completed NCT00181701 - Intraperitoneal Paclitaxel and Carboplatin in the Treatment of Women With Carcinoma of Mullerian Origin Phase 2
Terminated NCT00047632 - Safety and Efficacy of Interferon Gamma-1b Plus Chemotherapy for Ovarian and Peritoneal Cancer Phase 3
Recruiting NCT03302884 - Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma N/A
Completed NCT02166905 - DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission Phase 1/Phase 2
Recruiting NCT04851119 - Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors Phase 1/Phase 2