A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors

  • STATUS
    Recruiting
  • End date
    Mar 2, 2023
  • participants needed
    90
  • sponsor
    Fujifilm Pharmaceuticals U.S.A., Inc.
Updated on 2 May 2022

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.

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 15 patients in a 21 day cycle.

Details
Condition Advanced Solid Tumors
Treatment FF-10832 Gemcitabine Liposome Injection
Clinical Study IdentifierNCT03440450
SponsorFujifilm Pharmaceuticals U.S.A., Inc.
Last Modified on2 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 1
Histologically or cytologically confirmed cholangiocarcinoma or gall bladder carcinoma that is metastatic pancreatic adenocarcinoma following progression or relapseor unresectable
Life expectancy of ≥ 3 months
Ability to provide written informed consent
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

Exclusion Criteria

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)
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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