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Advanced Solid TumorsPhase 1NCT03440450

A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer

A Phase 1 study testing FF-10832 Gemcitabine Liposome Injection in people with Advanced Solid Tumors and Biliary Tract Cancer, run by Fujifilm Pharmaceuticals U.S.A., Inc. at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors, Biliary Tract Cancer
What is being tested?
FF-10832 Gemcitabine Liposome Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
7 sitesUnited States
Study dates
22 Mar 2018to Mar 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Sarah Cannon Research Institute

    Denver, Colorado, 80218

  • MD Anderson Cancer Research Center

    Houston, Texas, 77030

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Hoag Memorial Hospital Comprehensive Cancer Center

    Newport Beach, California, 92658

  • Honor Health Research Institute

    Scottsdale, Arizona, 85258

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719

Other trials in United States

About this study

Official title: A Phase 1 Dose-escalation Study of FF-10832 for the Treatment of Advanced Solid Tumors

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

Read the detailed 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.

Being tested
FF-10832 Gemcitabine Liposome Injection
Keywords
Liposomal gemcitabine
Medical subject headings
Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FF-10832 Gemcitabine Liposome InjectionDrug

    Also called FF-10832

    FF-10832 to be diluted in dextrose 5% in water (D5W) and intravenously infused at a continuous rate over 30 to 120 minutes

Study groups in NCT03440450
Study groupRoleWhat they receive
Cohort 1: Treatment at 1.2 mg/m2ExperimentalFF-10832 Gemcitabine Liposome Injection, 1.2 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Receives: Drug: FF-10832 Gemcitabine Liposome Injection
Cohort 2: Treatment at 2.4 mg/m2ExperimentalFF-10832 Gemcitabine Liposome Injection, 2.4 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Receives: Drug: FF-10832 Gemcitabine Liposome Injection
Cohort 3: Treatment at 4.8 mg/m2ExperimentalFF-10832 Gemcitabine Liposome Injection, 4.8 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Receives: Drug: FF-10832 Gemcitabine Liposome Injection
Cohort 4: Treatment at 8 mg/m2ExperimentalFF-10832 Gemcitabine Liposome Injection, 8 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Receives: Drug: FF-10832 Gemcitabine Liposome Injection
Expansion Cohort: Treatment at Recommended Phase 2 Dose (RP2D)ExperimentalFor patients with biliary tract cancer: FF-10832 Gemcitabine Liposome Injection, RP2D administered intravenously (IV) on Day 1 of each 21-day cycle
Receives: Drug: FF-10832 Gemcitabine Liposome Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine incidence of Treatment Emergent Adverse Events (TEAE)

    Safety and tolerability assessed by adverse events (AEs) and serious adverse events (SAEs)

    Measured: 2.5 years

  2. Identify dose-limiting toxicities (DLT) of FF-10832

    DLT is defined as any adverse event at least possibly related to FF-10832, and meeting specified DLT criteria

    Measured: 2.5 years

  3. Determine maximun tolerated dose (MTD) of FF-10832

    MTD is defined as the next lower dose of a cohort where patients experienced a DLT

    Measured: 2.5 years

Secondary outcomes (7)

  1. Disease Assessment by CT or MRI scan for solid tumors

    Disease assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1), clinical benefit is defined as best response of complete response (CR), partial response (PR), stable disease (SD) or disease progression (DP)

    Measured: 2.5 years

  2. Disease Assessment by CT or MRI + PET scan for pancreatic cancer

    For solid tumors assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST v. 1.1), clinical benefit is defined as best response of complete response (CR), partial response (PR), stable disease (SD) or disease progression (DP). European Organisation for Research and Treatment of Cancer (EORTC) criteria will be utilized for PET response assessments.

    Measured: 2.5 years

  3. Duration of Response

    Duration of Response is calculated from the date of first response to the date of progression or death

    Measured: 2.5 years

  4. Duration of Stable Disease

    Duration of Stable Disease is the length of time from the start of the treatment until the criteria for progression are met

    Measured: 2.5 years

  5. Time to progression (TTP)

    Time to progression is calculated from the date of first treatment to the date of first progression

    Measured: 2.5 years

  6. Progression-free survival (PFS)

    Progression-free survival will be calculated from the date of first treatment to the date of progression or death

    Measured: 2.5 years

  7. Overall survival (OS)

    Overall survival will be calculated from the date of first treatment to the date of death from any cause; patients who do not experience death will be censored at the last follow-up time.

    Measured: 2.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2018
  2. Study start22 Mar 2018
  3. Primary completionOct 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Open label, dose escalation
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03440450
Sponsor's protocol ID
FF10832US101
Status last verified
Aug 2026
First submitted
9 Feb 2018
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FF-10832 Gemcitabine Liposome Injection in people with Advanced Solid Tumors and Biliary Tract Cancer, run by Fujifilm Pharmaceuticals U.S.A., Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine incidence of Treatment Emergent Adverse Events (TEAE) (time frame: 2.5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03440450.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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