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

  • STATUS
    Recruiting
  • End date
    Jul 29, 2025
  • participants needed
    96
  • sponsor
    Fujifilm Pharmaceuticals U.S.A., Inc.
Updated on 29 July 2021

Summary

To determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended Phase 2 dose (RP2D) of FF-10850 (topotecan liposome injection) in patients with advanced solid tumors.

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 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.

Details
Condition Advanced Solid Tumors
Treatment FF-10850 Topotecan Liposome Injection
Clinical Study IdentifierNCT04047251
SponsorFujifilm Pharmaceuticals U.S.A., Inc.
Last Modified on29 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must meet all the following criteria to participate in the study
Males and females 18 years of age
Dose-escalation phase: Histologically or cytologically confirmed metastatic and/or unresectable solid tumor, relapsed or refractory to standard therapy, or for which no standard therapy is available that is expected to improve survival by at least 3 months
At least 3 weeks beyond the last chemotherapy (or 3 half-lives, whichever is shorter), radiotherapy, major surgery, or experimental treatment, and recovered from all acute toxicities ( Grade 1), prior to the first dose of FF-10850
Adequate performance status: Eastern Cooperative Oncology Group (ECOG) 1
Life expectancy of 3 months
Adequate hematologic parameters without ongoing transfusion support
Hemoglobin (Hb) 9 g/dL
Absolute neutrophil count (ANC) 1.0 109 cells/L
Platelets 100 109 cells/L
Creatinine 1.5 ULN, or calculated creatinine clearance 50 mL/minute by either the Cockcroft-Gault formula or as measured by a 24-hour urine collection
Total bilirubin 2 ULN unless due to Gilbert's disease; patients with Gilbert's disease who have a total bilirubin > 6 mg/dL are to be excluded
ALT and AST 2.5 times ULN, or < 5 ULN for patients with liver metastases
QT interval corrected for rate (QT interval corrected for rate using Fridericia's Correction Formula, QTcF) 470 msec for women and 450 msec for men on the ECG obtained at Screening and confirmed pre-treatment on Cycle 1 Day 1
Patient must be willing to undergo a tumor biopsy, if the patient has a biopsy-accessible tumor

Exclusion Criteria

Patients who have not received standard/approved therapies expected to improve survival by at least 3 months
History of severe hypersensitivity reactions to topotecan
Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV or hereditary long QT syndrome
Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, except for antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care
Active central nervous system (CNS) malignant disease in patients with a history of CNS malignancy. Patients with previously treated stable brain metastases are allowed if they have been stable off steroid therapy for at least 4 weeks
Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV)
Active infection requiring intravenous (IV) antibiotic usage within the last week prior to study treatment
Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results
Pregnant or breast-feeding
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