Status and phase
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About
To determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLT) and recommended Phase 2 dose (RP2D) in patients who receive FF-10832 (Gemcitabine Liposome Injection) for treatment of advanced solid tumors including biliary tract cancer
Full description
Dose-escalation Phase:
Eligible patients will receive FF-10832 in 28 day or 21 day cycles. Dosing will continue until progression of disease, observation of unacceptable adverse events, intercurrent illness, or changes in the patient's condition that prevents further study participation after discussion between the Investigator and the Medical Monitor. A number of cohorts will be enrolled sufficient to determine the MTD and to identify the RP2D.
Expansion Phase:
One cohort of biliary tract cancer will enroll up to 18 patients in a 21 day cycle.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Males and females ≥ 18 years of age
Histologically or cytologically confirmed metastatic 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 three 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-10832
Cohort expansion phase: (biliary tract cancer):
Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 1
Life expectancy of ≥ 3 months
Ability to provide written informed consent
Exclusion criteria
Patients who have not received standard/approved therapies expected to improve survival by at least 3 months
Prior hypersensitivity to gemcitabine
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
Primary purpose
Allocation
Interventional model
Masking
90 participants in 5 patient groups
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Central trial contact
FPHU Study Coordinator
Data sourced from clinicaltrials.gov
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