A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer
NCT ID: NCT03440450
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
90 participants
INTERVENTIONAL
2018-03-22
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: Treatment at 1.2 mg/m2
FF-10832 Gemcitabine Liposome Injection, 1.2 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
FF-10832 Gemcitabine Liposome Injection
FF-10832 to be diluted in dextrose 5% in water (D5W) and intravenously infused at a continuous rate over 30 to 120 minutes
Cohort 2: Treatment at 2.4 mg/m2
FF-10832 Gemcitabine Liposome Injection, 2.4 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
FF-10832 Gemcitabine Liposome Injection
FF-10832 to be diluted in dextrose 5% in water (D5W) and intravenously infused at a continuous rate over 30 to 120 minutes
Cohort 3: Treatment at 4.8 mg/m2
FF-10832 Gemcitabine Liposome Injection, 4.8 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
FF-10832 Gemcitabine Liposome Injection
FF-10832 to be diluted in dextrose 5% in water (D5W) and intravenously infused at a continuous rate over 30 to 120 minutes
Cohort 4: Treatment at 8 mg/m2
FF-10832 Gemcitabine Liposome Injection, 8 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
FF-10832 Gemcitabine Liposome Injection
FF-10832 to be diluted in dextrose 5% in water (D5W) and intravenously infused at a continuous rate over 30 to 120 minutes
Expansion Cohort: Treatment at Recommended Phase 2 Dose (RP2D)
For patients with biliary tract cancer: FF-10832 Gemcitabine Liposome Injection, RP2D administered intravenously (IV) on Day 1 of each 21-day cycle
FF-10832 Gemcitabine Liposome Injection
FF-10832 to be diluted in dextrose 5% in water (D5W) and intravenously infused at a continuous rate over 30 to 120 minutes
Interventions
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FF-10832 Gemcitabine Liposome Injection
FF-10832 to be diluted in dextrose 5% in water (D5W) and intravenously infused at a continuous rate over 30 to 120 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Fujifilm Pharmaceuticals U.S.A., Inc.
INDUSTRY
Responsible Party
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Locations
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Honor Health Research Institute
Scottsdale, Arizona, United States
University of Arizona Cancer Center
Tucson, Arizona, United States
Hoag Memorial Hospital Comprehensive Cancer Center
Newport Beach, California, United States
Sarah Cannon Research Institute
Denver, Colorado, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson Cancer Research Center
Houston, Texas, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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FF10832US101
Identifier Type: -
Identifier Source: org_study_id
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