A Study of FF-10850 Topotecan Liposome Injection in Advanced Solid Tumors Including Merkel Cell Cā¦ (NCT04047251) | Clinical Trial Compass
Active ā Not RecruitingPhase 1
A Study of FF-10850 Topotecan Liposome Injection in Advanced Solid Tumors Including Merkel Cell Carcinoma
United States96 participantsStarted 2019-11-14
Plain-language 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 including Merkel Cell Carcinoma
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Males and females ā„ 18 years of age
ā. 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
ā. 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 (ā¤ Grade 1), prior to the first dose of FF-10850
ā. Adequate hematologic parameters without ongoing transfusion support:
ā. Creatinine ā¤ 1.5 Ć ULN, or calculated creatinine clearance ā„ 50 mL/minute by either the Cockcroft-Gault formula or as measured by a 24-hour urine collection
ā. Total bilirubin ā¤ 2 Ć ULN unless due to Gilbert's disease; patients with Gilbert's disease who have a total bilirubin \> 6 mg/dL are to be excluded
Exclusion criteria
ā. Patients who have not received standard/approved therapies expected to improve survival by at least 3 months
ā. History of severe hypersensitivity reactions to topotecan
ā. 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
What they're measuring
1
Determine incidence of Treatment Emergent Adverse Events
Timeframe: 4 years
2
Identify dose-limiting toxicities (DLT) of FF-10850
Timeframe: 4 years
3
Determine maximun tolerated dose (MTD) of FF-10850
ā. 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
ā. 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.
ā. Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV)
ā. Active infection requiring intravenous (IV) antibiotic usage within the last week prior to study treatment
ā. 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