NCT03440450Active, not recruitingPhase 1
A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer
A Phase 1 Dose-escalation Study of FF-10832 for the Treatment of Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 9 Feb 2018
- Start date
- 22 Mar 2018
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Fujifilm Pharmaceuticals U.S.A., Inc.
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT03440450
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 90
- From 22 Mar 2018 to the primary completion date, 31 Oct 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- 7\. Active infection requiring intravenous (IV) antibiotic usage within the last week prior to study treatment
- 8\. 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
- 9\. Pregnant or breast-feeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| MD Anderson Cancer Research Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Sarah Cannon Research Institute Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Hoag Memorial Hospital Comprehensive Cancer Center Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Honor Health Research Institute Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Virginia Mason Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| University of Arizona Cancer Center Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.