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Advanced Solid TumorsPhase 1NCT04047251

A Study of FF-10850 Topotecan Liposome Injection in Advanced Solid Tumors Including Merkel Cell Carcinoma

A Phase 1 study testing FF-10850 Topotecan Liposome Injection in people with Advanced Solid Tumors and Merkel Cell Carcinoma, 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 (DLTs), and recommended Phase 2 dose (RP2D) of FF-10850 (topotecan liposome injection) in patients with advanced solid tumors including Merkel Cell Carcinoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors, Merkel Cell Carcinoma
What is being tested?
FF-10850 Topotecan Liposome Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
7 sitesUnited States
Study dates
14 Nov 2019to 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

  • Patients must meet all the following criteria to participate in the study:
  • Males and females ≥ 18 years of age
  • Dose-escalation phase: Histologically or cytologically confirmed metastatic and/or unresectable 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 3 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-10850
  • Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 1
  • Life expectancy of ≥ 3 months
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  • Adequate hematologic parameters without ongoing transfusion support:
  • Hemoglobin (Hb) ≥ 9 g/dL
  • Absolute neutrophil count (ANC) ≥ 1.0 × 109 cells/L
  • Platelets ≥ 100 × 109 cells/L
  • Creatinine ≤ 1.5 × ULN, or calculated creatinine clearance ≥ 50 mL/minute by either the Cockcroft-Gault formula or as measured by a 24-hour urine collection
  • Total bilirubin ≤ 2 × ULN unless due to Gilbert's disease; patients with Gilbert's disease who have a total bilirubin > 6 mg/dL are to be excluded
  • ALT and AST ≤ 2.5 times ULN, or < 5 × ULN for patients with liver metastases
  • QT interval corrected for rate (QT interval corrected for rate using Fridericia's Correction Formula, QTcF) ≤ 470 msec for women and ≤ 450 msec for men on the ECG obtained at Screening and confirmed pre-treatment on Cycle 1 Day 1.
  • Patient must be willing to undergo a tumor biopsy, if the patient has a biopsy-accessible tumor

Who cannot join

  • Patients who have not received standard/approved therapies expected to improve survival by at least 3 months
  • History of severe hypersensitivity reactions to topotecan
  • Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV or hereditary long QT syndrome
  • Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, except for antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care
  • Active central nervous system (CNS) malignant disease in patients with a history of CNS malignancy. Patients with previously treated stable brain metastases are allowed if they have been stable off steroid therapy for at least 4 weeks.
  • Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV)
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  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Dana Farber Cancer Institute (DFCI)

    Boston, Massachusetts, 02215

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43221

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Wisconsin Clinical Science Center

    Madison, Wisconsin, 53792

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • HonorHealth

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: A Phase 1 Study of FF-10850 Topotecan Liposome Injection in Advanced Solid Tumors Including Ovarian and Cervical Carcinoma, Sarcomas, and Neuroendocrine Tumors Including Small Cell Lung Cancer and Merkel Cell Carcinoma

To determine the safety profile, maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended Phase 2 dose (RP2D) of FF-10850 (topotecan liposome injection) in patients with advanced solid tumors including Merkel Cell Carcinoma

Read the detailed description

Dose-escalation Phase: Approximately 48 patients are planned for the dose-escalation phase, with at least 6 patients treated at the RP2D.

Cohort Expansion Phase: Two additional cohorts are planned. Cohort E1: advanced ovarian cancer and Cohort E5 Merkel cell carcinoma. Each cohort will be treated at the RP2D.

In each cohort, FF-10850 will be administered intravenously (IV) until progression of disease, observation of unacceptable AEs, or, after discussion between the Investigator and the Medical Monitor, changes in the patient's condition that prevent further study participation. A sufficient number of cohorts will be enrolled to identify the RP2D.

There will be 3 initial dose levels in this study. FF-10850 will be diluted and infused over 60 minutes.

Approximately 96 patients are planned for the entire trial.

It is anticipated that approximately 4 centers will participate in the dose-escalation phase, with an expansion to approximately 10 centers in the cohort expansion phase. Accrual for the dose-escalation and expansion phases is expected to be approximately 3 years, with patients followed every 3 months from the last dose of study treatment to assess survival.

Being tested
FF-10850 Topotecan Liposome Injection
Medical subject headings
Carcinoma, Merkel Cell

What participants receive

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

  • FF-10850 Topotecan Liposome InjectionDrug

    Also called FF-10850

    FF-10850 to be diluted and infused over 60 minutes.

Study groups in NCT04047251
Study groupRoleWhat they receive
Cohort 1: Treatment at Dose Level 1ExperimentalFF-10850 Topotecan Liposome Injection, Dose Level 1 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Receives: Drug: FF-10850 Topotecan Liposome Injection
Cohort 2: Treatment at Dose Level 2ExperimentalFF-10850 Topotecan Liposome Injection, Dose Level 2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Receives: Drug: FF-10850 Topotecan Liposome Injection
Cohort 3: Treatment at Dose Level 3ExperimentalFF-10850 Topotecan Liposome Injection, Dose Level 3 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Receives: Drug: FF-10850 Topotecan Liposome Injection
Cohort E1: Treatment at Recommended Phase 2 Dose (RP2D)ExperimentalFor patients with advanced ovarian cancer: FF-10850 Topotecan Liposome Injection, RP2D administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Receives: Drug: FF-10850 Topotecan Liposome Injection
Cohort E5: Treatment at Recommended Phase 2 Dose (RP2D)ExperimentalFor patients with advanced Merkel cell carcinoma: FF-10850 Topotecan Liposome Injection, RP2D administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Receives: Drug: FF-10850 Topotecan 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

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

    Measured: 4 years

  2. Identify dose-limiting toxicities (DLT) of FF-10850

    DLT is defined as any adverse event at least possibly related to FF-10850, and meeting specified DLT criteria

    Measured: 4 years

  3. Determine maximun tolerated dose (MTD) of FF-10850

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

    Measured: 4 years

  4. Determine recommended Phase 2 dose (RP2D) FF-10850

    The highest dose level below the dose level eliciting DLT in ≥ 2 patients will be declared the MTD. The RP2D will be chosen based on the MTD or on PK and biological activity if an MTD has not been determined.

    Measured: 4 years

Secondary outcomes (12)

  1. Characterize the pharmacokinetics (PK) of FF-10850 in plasma: Cmax

    Measurement of maximum plasma concentration

    Measured: 4 years

  2. Characterize the pharmacokinetics (PK) of FF-10850 in plasma: tmax

    Measurement of time to reach Cmax

    Measured: 4 years

  3. Characterize the pharmacokinetics (PK) of FF-10850 in plasma: t1/2

    Measurement of the elimination half-life

    Measured: 4 years

  4. Characterize the pharmacokinetics (PK) of FF-10850 in plasma: AUC

    Measurement of the area under the curve of plasma concentration versus time profile

    Measured: 4 years

  5. Characterize the pharmacokinetics (PK) of FF-10850 in plasma: MRT

    Measurement of the mean residence time adjusted for duration of infusion

    Measured: 4 years

  6. Characterize the pharmacokinetics (PK) of FF-10850 in plasma: CL

    Measurement of the total plasma clearance

    Measured: 4 years

  7. Characterize the pharmacokinetics (PK) of FF-10850 in plasma: Vss

    Measurement of the steady-state volume of distribution for total topotecan

    Measured: 4 years

  8. Determine objective response rate (ORR)

    classified for solid tumors via RECIST v.1.1

    Measured: 4 years

  9. Determine the duration of response (DOR)

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

    Measured: 4 years

  10. Determine the time to progression (TTP)

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

    Measured: 4 years

  11. Evaluate progression-free survival (PFS)

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

    Measured: 4 years

  12. Evaluate overall survival (OS) (expansion cohorts only)

    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: 4 years

Timeline

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

  1. First posted6 Aug 2019
  2. Study start14 Nov 2019
  3. Primary completionDec 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
Sequential
Model description
Open label, dose escalation
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04047251
Sponsor's protocol ID
FF10850US101
Status last verified
Aug 2026
First submitted
1 Aug 2019
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shimoyama S, Okada K, Kimura T, Morohashi Y, Nakayama S, Kemmochi S, Makita-Suzuki K, Matulonis UA, Mori M. FF-10850, a Novel Liposomal Topotecan Achieves Superior Antitumor Activity via Macrophage- and Ammonia-Mediated Payload Release in the Tumor Microenvironment. Mol Cancer Ther. 2023 Dec 1;22(12):1454-1464. doi: 10.1158/1535-7163.MCT-23-0099.

    PubMed 37683276

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FF-10850 Topotecan Liposome Injection in people with Advanced Solid Tumors and Merkel Cell Carcinoma, 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 15 inclusion and 9 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 (time frame: 4 years). The study lists 4 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 NCT04047251, which also lists 1 linked publication.

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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