A Study of FF-10850 Topotecan Liposome Injection in Advanced Solid Tumors

Summary

Participation Requirements

Description

Dose-escalation Phase: Approximately 48 patients are planned for the dose-escalation phase, with at least 6 patients treated at the RP2D. Cohort Expansion Phase: Four additional cohorts of 12 patients each are planned. Cohort E1: advanced ovarian cancer; Cohort E2: advanced cervical cancer, Cohort E...

Dose-escalation Phase: Approximately 48 patients are planned for the dose-escalation phase, with at least 6 patients treated at the RP2D. Cohort Expansion Phase: Four additional cohorts of 12 patients each are planned. Cohort E1: advanced ovarian cancer; Cohort E2: advanced cervical cancer, Cohort E3: advanced sarcomas, and Cohort E4: advanced neuroendocrine tumors including small cell lung cancer. Each cohort will be treated at the RP2D. In each cohort, FF-10850 will be administered intravenously (IV) until progression of disease, observation of unacceptable AEs, or, after discussion between the Investigator and the Medical Monitor, changes in the patient's condition that prevent further study participation. A sufficient number of cohorts will be enrolled to identify the RP2D. There will be 3 initial dose levels in this study. FF-10850 will be diluted and infused over 60 minutes. Approximately 96 patients are planned for the entire trial. It is anticipated that approximately 4 centers will participate in the dose-escalation phase, with an expansion to approximately 10 centers in the cohort expansion phase. Accrual for the dose-escalation and expansion phases is expected to be approximately 3 years, with patients followed every 3 months from the last dose of study treatment to assess survival.

Tracking Information