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

Primary Purpose

Advanced Solid Tumors

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
FF-10832 Gemcitabine Liposome Injection
Sponsored by
Fujifilm Pharmaceuticals U.S.A., Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumors focused on measuring Liposomal gemcitabine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Honor Health Research InstituteRecruiting
  • University of Arizona Cancer CenterRecruiting
  • Hoag Memorial Hospital Comprehensive Cancer Center
  • Sarah Cannon Research InstituteRecruiting
  • Sarah Cannon Research Institute
  • MD Anderson Cancer Research Center
  • Virginia Mason Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Determine incidence of Treatment Emergent Adverse Events (TEAE)
Safety and tolerability assessed by adverse events (AEs) and serious adverse events (SAEs)
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
Determine maximun tolerated dose (MTD) of FF-10832
MTD is defined as the next lower dose of a cohort where patients experienced a DLT

Secondary Outcome Measures

Disease Assessment by CT or MRI scan for solid tumors
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)
Disease Assessment by CT or MRI + PET scan for pancreatic cancer
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
Duration of Response is calculated from the date of first response to the date of progression or death
Duration of Stable Disease
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)
Time to progression is calculated from the date of first treatment to the date of first progression
Progression-free survival (PFS)
Progression-free survival will be calculated from the date of first treatment to the date of progression or death
Overall survival (OS)
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.

Full Information

First Posted
February 9, 2018
Last Updated
October 12, 2023
Sponsor
Fujifilm Pharmaceuticals U.S.A., Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03440450
Brief Title
A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors
Official Title
A Phase 1 Dose-escalation Study of FF-10832 for the Treatment of Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2018 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujifilm Pharmaceuticals U.S.A., Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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 15 patients in a 21 day cycle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors
Keywords
Liposomal gemcitabine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Open label, dose escalation
Masking
None (Open Label)
Masking Description
None, open label
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Treatment at 1.2 mg/m2
Arm Type
Experimental
Arm Description
FF-10832 Gemcitabine Liposome Injection, 1.2 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Arm Title
Cohort 2: Treatment at 2.4 mg/m2
Arm Type
Experimental
Arm Description
FF-10832 Gemcitabine Liposome Injection, 2.4 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Arm Title
Cohort 3: Treatment at 4.8 mg/m2
Arm Type
Experimental
Arm Description
FF-10832 Gemcitabine Liposome Injection, 4.8 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Arm Title
Cohort 4: Treatment at 8 mg/m2
Arm Type
Experimental
Arm Description
FF-10832 Gemcitabine Liposome Injection, 8 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
Arm Title
Expansion Cohort: Treatment at Recommended Phase 2 Dose (RP2D)
Arm Type
Experimental
Arm Description
For patients with biliary tract cancer: FF-10832 Gemcitabine Liposome Injection, RP2D administered intravenously (IV) on Day 1 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
FF-10832 Gemcitabine Liposome Injection
Other Intervention Name(s)
FF-10832
Intervention Description
FF-10832 to be diluted in dextrose 5% in water (D5W) and intravenously infused at a continuous rate over 30 to 120 minutes
Primary Outcome Measure Information:
Title
Determine incidence of Treatment Emergent Adverse Events (TEAE)
Description
Safety and tolerability assessed by adverse events (AEs) and serious adverse events (SAEs)
Time Frame
2.5 years
Title
Identify dose-limiting toxicities (DLT) of FF-10832
Description
DLT is defined as any adverse event at least possibly related to FF-10832, and meeting specified DLT criteria
Time Frame
2.5 years
Title
Determine maximun tolerated dose (MTD) of FF-10832
Description
MTD is defined as the next lower dose of a cohort where patients experienced a DLT
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
Disease Assessment by CT or MRI scan for solid tumors
Description
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)
Time Frame
2.5 years
Title
Disease Assessment by CT or MRI + PET scan for pancreatic cancer
Description
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.
Time Frame
2.5 years
Title
Duration of Response
Description
Duration of Response is calculated from the date of first response to the date of progression or death
Time Frame
2.5 years
Title
Duration of Stable Disease
Description
Duration of Stable Disease is the length of time from the start of the treatment until the criteria for progression are met
Time Frame
2.5 years
Title
Time to progression (TTP)
Description
Time to progression is calculated from the date of first treatment to the date of first progression
Time Frame
2.5 years
Title
Progression-free survival (PFS)
Description
Progression-free survival will be calculated from the date of first treatment to the date of progression or death
Time Frame
2.5 years
Title
Overall survival (OS)
Description
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.
Time Frame
2.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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): 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 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) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FPHU Study Coordinator
Email
fphucontact@fujifilm.com
Facility Information:
Facility Name
Honor Health Research Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Name
Hoag Memorial Hospital Comprehensive Cancer Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Sarah Cannon Research Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
MD Anderson Cancer Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Completed
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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