Can a new gemcitabine formulation outsmart advanced solid tumors?
NCT ID NCT03440450
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This phase 1 trial tests FF-10832, a liposomal version of the chemotherapy drug gemcitabine, in adults with advanced solid tumors, including biliary tract cancer, that have not responded to standard treatment or have no standard options. Researchers give the drug as an intravenous infusion and gradually increase the dose to find the highest safe amount. The main goals are to assess safety, identify side effects, and determine the recommended dose for future studies.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FF-10832, a liposomal form of the chemotherapy drug gemcitabine, given as an intravenous infusion
- What this could lead to
- If it works, this could lead to a new treatment option for advanced solid tumors, including biliary tract cancer, that have stopped responding to standard therapies.
- What could go wrong
- This is an early phase 1 trial, so the main goal is safety and dosing, not proof of effectiveness. The drug may cause side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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90 people
The number who actually took part.
- Started
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Mar 2018
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males and females ≥ 18 years of age 2. 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 3. 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 4. 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 5. Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 1 6. Life expectancy of ≥ 3 months 7. Ability to provide written informed consent Exclusion Criteria: 1. Patients who have not received standard/approved therapies expected to improve survival by at least 3 months 2. Prior hypersensitivity to gemcitabine 3. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hoag Memorial Hospital Comprehensive Cancer Center
Newport Beach, California, 92658, United States
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Honor Health Research Institute
Scottsdale, Arizona, 85258, United States
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MD Anderson Cancer Research Center
Houston, Texas, 77030, United States
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Sarah Cannon Research Institute
Denver, Colorado, 80218, United States
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Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
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University of Arizona Cancer Center
Tucson, Arizona, 85719, United States
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Virginia Mason Medical Center
Seattle, Washington, 98101, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A multicenter, Dose-Escalation and expansion phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy of SGT003 in patients with advanced solid tumors
- A phase II/III randomized clinical trial of CisPlatin plUs gemcitabine and nabpaclitaxel (GAP) as pReoperative chemotherapy versus immediate resection in patIents with resecTable BiliarY tract cancers (BTC) at high risk for recurrence: PURITY study
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