A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer
Running, not enrolling · Phase 1
Conditions studied: Advanced Solid Tumors, Biliary Tract Cancer
In brief
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
Key facts
- Study ID
- NCT03440450
- Run by
- Fujifilm Pharmaceuticals U.S.A., Inc.
- People needed
- 90
- Starts
- 2018-03-22
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-05-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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):
- Histologically or cytologically confirmed cholangiocarcinoma or gall bladder carcinoma that is metastatic pancreatic adenocarcinoma following progression or relapseor unresectable
- Measurable disease by RECIST 1.1
- Progressed on at least one prior regimengemcitabine-cisplatin therapy or gemcitabine-based therapy if unable to tolerate cisplatin. Adjuvant therapy counts as such therapy.
- Progressed on, declined on, or was ineligible for therapies directed against fibroblast growth factor (FGFR) and/or isocitrate dehydrogenase (IDH) mutations for tumors appropriately treated with such therapies
- No more than 3 prior systemic therapies for their tumor. Please contact the medical monitor if there are any questions about eligibility.
- A serum albumin level ≥ 3 g/dL on entry to the study
- Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 1
- Life expectancy of ≥ 3 months
- Ability to provide written informed consent
You may not qualify if…
- 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
Where it is running
- Honor Health Research Institute — Scottsdale, Arizona, United States
- University of Arizona Cancer Center — Tucson, Arizona, United States
- Hoag Memorial Hospital Comprehensive Cancer Center — Newport Beach, California, United States
- Sarah Cannon Research Institute — Denver, Colorado, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- MD Anderson Cancer Research Center — Houston, Texas, United States
- Virginia Mason Medical Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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