US-based pharmaceutical firm NanOlogy has started patient enrolment in a Phase II clinical trial of intraperitoneal (IP) NanoPac (nanoparticle paclitaxel) sterile suspension to treat ovarian cancer.
Part of the firm’s nanoparticle technology platform, NanoPac is stable without coating agents and can be suspended in simple vehicles before use.
The randomised, open-label, parallel Phase II trial is designed to assess the safety and efficacy of IP instillation of 100mg/m², 200mg/m², 300mg/m² and 400mg/m² NanoPac given immediately after cytoreductive (debulking) surgery.
NanoPac administered in combination with standard-of-care (SOC) intravenous (IV) chemotherapy of carboplatin and paclitaxel will be compared to SOC IV chemotherapy alone.
NanOlogy Medical Affairs vice-president Gere diZerega said: “Systemically administered paclitaxel has been shown to be effective in ovarian cancer but is limited by its adverse effects.
“We are attempting to show that a single, IP-instilled dose of NanoPac will effectively treat the cancer with high locally sustained concentrations of the drug and no contribution to systemic adverse effects.”
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The primary outcome measures of the trial are treatment-emergent adverse events and progression-free survival at 12 months, while the secondary outcomes include maximum plasma concentration of paclitaxel.
Expected to be complete by September 2019, the trial will include approximately 61 subjects.
In addition to ovarian cancer, NanoPac sterile suspension is being studied for the treatment of prostate cancer and pancreatic cancer through an intratumoral route, and for treating pancreatic mucinous cyst by intracystic administration.