A Study of FF-10850 Topotecan Liposome Injection in Advanced Solid Tumors Including Merkel Cell Carcinoma

Running, not enrolling · Phase 1

Conditions studied: Advanced Solid Tumors, Merkel Cell Carcinoma

In brief

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 including Merkel Cell Carcinoma

Key facts

Study ID: NCT04047251
Run by: Fujifilm Pharmaceuticals U.S.A., Inc.
People needed: 96
Starts: 2019-11-14
Expected to finish: 2026-07-01
Last updated by the study team: 2025-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

HonorHealth — Scottsdale, Arizona, United States
Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
Dana Farber Cancer Institute (DFCI) — Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Ohio State University Wexner Medical Center — Columbus, Ohio, United States
MD Anderson Cancer Center — Houston, Texas, United States
University of Wisconsin Clinical Science Center — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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