This Phase II study is designed to determine if IT-101 treatment initiated after a standard second line course of platinum chemotherapy in patients who have stable disease, a partial response or a complete response can delay disease progression. The study is expected to enroll 150 patients in the US.
A team of experts from Dana Farber, Sloan Kettering, Columbia University, and MD Anderson comprise the data safety monitoring committee.
According to the company, IT-101, a conjugate of camptothecin and Insert’s proprietary cyclodextrin polymer nanoparticle, Cyclosert, has demonstrated a highly favorable toxicity profile and pharmacokinetic characteristics.
Previous work with IT-101 suggests that twice monthly ‘maintenance doses’ of IT-101 given after the patient’s standard chemotherapy may have minimal side effects, allowing for improved quality of life, and improved progression free survival.