Advanced Solid Tumors, Biliary Tract Cancer
Conditions
Keywords
Liposomal gemcitabine
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
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.
Interventions
DRUGFF-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
Sponsors
Fujifilm Pharmaceuticals U.S.A., Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
None, open label
Intervention model description
Open label, dose escalation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females ≥ 18 years of age 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
1. Patients who have not received standard/approved therapies expected to improve survival by at least 3 months 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine incidence of Treatment Emergent Adverse Events (TEAE) | 2.5 years | Safety and tolerability assessed by adverse events (AEs) and serious adverse events (SAEs) |
| Identify dose-limiting toxicities (DLT) of FF-10832 | 2.5 years | DLT is defined as any adverse event at least possibly related to FF-10832, and meeting specified DLT criteria |
| Determine maximun tolerated dose (MTD) of FF-10832 | 2.5 years | MTD is defined as the next lower dose of a cohort where patients experienced a DLT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Stable Disease | 2.5 years | Duration of Stable Disease is the length of time from the start of the treatment until the criteria for progression are met |
| Time to progression (TTP) | 2.5 years | Time to progression is calculated from the date of first treatment to the date of first progression |
| Disease Assessment by CT or MRI scan for solid tumors | 2.5 years | 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) |
| Overall survival (OS) | 2.5 years | 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. |
| Progression-free survival (PFS) | 2.5 years | Progression-free survival will be calculated from the date of first treatment to the date of progression or death |
| Disease Assessment by CT or MRI + PET scan for pancreatic cancer | 2.5 years | 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. |
| Duration of Response | 2.5 years | Duration of Response is calculated from the date of first response to the date of progression or death |
Countries
United States
Outcome results
None listed