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

NCT03440450 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: FF10832US101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 7

Brief 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

Conditions

Advanced Solid Tumors; Biliary Tract Cancer

Keywords

Liposomal gemcitabine

Outcome Measures

Primary Outcomes (3)

• Determine incidence of Treatment Emergent Adverse Events (TEAE)

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

  2.5 years

• 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

  2.5 years

• Determine maximun tolerated dose (MTD) of FF-10832

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

  2.5 years

Secondary Outcomes (7)

• Disease Assessment by CT or MRI scan for solid tumors

  2.5 years

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

  2.5 years

• Duration of Response

  2.5 years

• Duration of Stable Disease

  2.5 years

• Time to progression (TTP)

  2.5 years

Study Arms (5)

Cohort 1: Treatment at 1.2 mg/m2

EXPERIMENTAL

FF-10832 Gemcitabine Liposome Injection, 1.2 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle

Drug: FF-10832 Gemcitabine Liposome Injection

Cohort 2: Treatment at 2.4 mg/m2

EXPERIMENTAL

FF-10832 Gemcitabine Liposome Injection, 2.4 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle

Drug: FF-10832 Gemcitabine Liposome Injection

Cohort 3: Treatment at 4.8 mg/m2

EXPERIMENTAL

FF-10832 Gemcitabine Liposome Injection, 4.8 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle

Drug: FF-10832 Gemcitabine Liposome Injection

Cohort 4: Treatment at 8 mg/m2

EXPERIMENTAL

FF-10832 Gemcitabine Liposome Injection, 8 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle

Drug: FF-10832 Gemcitabine Liposome Injection

Expansion Cohort: Treatment at Recommended Phase 2 Dose (RP2D)

EXPERIMENTAL

For patients with biliary tract cancer: FF-10832 Gemcitabine Liposome Injection, RP2D administered intravenously (IV) on Day 1 of each 21-day cycle

Drug: FF-10832 Gemcitabine Liposome Injection

Interventions

FF-10832 Gemcitabine Liposome Injection DRUG

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

Also known as: FF-10832

Cohort 1: Treatment at 1.2 mg/m2; Cohort 2: Treatment at 2.4 mg/m2; Cohort 3: Treatment at 4.8 mg/m2; Cohort 4: Treatment at 8 mg/m2; Expansion Cohort: Treatment at Recommended Phase 2 Dose (RP2D)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujifilm Pharmaceuticals U.S.A., Inc.: lead

Study Sites (7)

Honor Health Research Institute

Scottsdale, Arizona, 85258, United States

Location

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

Hoag Memorial Hospital Comprehensive Cancer Center

Newport Beach, California, 92658, United States

Location

Sarah Cannon Research Institute

Denver, Colorado, 80218, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Research Center

Houston, Texas, 77030, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: None, open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, dose escalation

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 22, 2018
• Study Start: March 22, 2018
• Primary Completion: May 15, 2025
• Study Completion: December 1, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)