Can a new gemcitabine formulation outsmart advanced solid tumors?

NCT ID NCT03440450

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

90 people

The number who actually took part.

Started

Mar 2018

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

biliary tract cancer Biliary Tract Neoplasms neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hoag Memorial Hospital Comprehensive Cancer Center

    Newport Beach, California, 92658, United States

  • Honor Health Research Institute

    Scottsdale, Arizona, 85258, United States

  • MD Anderson Cancer Research Center

    Houston, Texas, 77030, United States

  • Sarah Cannon Research Institute

    Denver, Colorado, 80218, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

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