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A Phase 1 Dose-escalation Study of FF-10832 Monotherapy or in Combo With Nab-paclitaxel for Treatment of Solid Tumors

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ClinicalTrials.gov Identifier: NCT03440450
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : August 20, 2020
Sponsor:
Information provided by (Responsible Party):
Fujifilm Pharmaceuticals U.S.A., Inc.

Tracking Information
First Submitted Date  ICMJE February 9, 2018
First Posted Date  ICMJE February 22, 2018
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE March 22, 2018
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
  • Determine incidence of Treatment Emergent Adverse Events (TEAE) [ Time Frame: 2.5 years ]
    Safety and tolerability assessed by adverse events (AEs) and serious adverse events (SAEs)
  • Identify dose-limiting toxicities (DLT) of FF-10832 [ Time Frame: 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 [ Time Frame: 2.5 years ]
    MTD is defined as the next lower dose of a cohort where patients experienced a DLT
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
  • Disease Assessment by CT or MRI scan for solid tumors [ Time Frame: 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)
  • Disease Assessment by CT or MRI + PET scan for pancreatic cancer [ Time Frame: 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 [ Time Frame: 2.5 years ]
    Duration of Response is calculated from the date of first response to the date of progression or death
  • Duration of Stable Disease [ Time Frame: 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) [ Time Frame: 2.5 years ]
    Time to progression is calculated from the date of first treatment to the date of first progression
  • Progression-free survival (PFS) [ Time Frame: 2.5 years ]
    Progression-free survival will be calculated from the date of first treatment to the date of progression or death
  • Overall survival (OS) [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Dose-escalation Study of FF-10832 Monotherapy or in Combo With Nab-paclitaxel for Treatment of Solid Tumors
Official Title  ICMJE A Phase 1 Dose-escalation Study of FF-10832 Monotherapy or in Combination With Nab-paclitaxel for the Treatment of Advanced Solid Tumors
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 alone in either 21 or 28 day cycles, or in combination with nab-paclitaxel in a 28 day cycle. 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 Once 6 patients are treated at the MTD or RP2D in each regimen during the dose-escalation phase, it is anticipated that up to three additional cohorts, distributed among the regimens, may enroll up to 12 patients each.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Open label, dose escalation
Masking: None (Open Label)
Masking Description:
None, open label
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE Drug: 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
Study Arms  ICMJE
  • Experimental: 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
    Intervention: Drug: FF-10832 Gemcitabine Liposome Injection
  • Experimental: 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
    Intervention: Drug: FF-10832 Gemcitabine Liposome Injection
  • Experimental: 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
    Intervention: Drug: FF-10832 Gemcitabine Liposome Injection
  • Experimental: 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
    Intervention: Drug: FF-10832 Gemcitabine Liposome Injection
  • Experimental: Cohort 5: Treatment at 12 mg/m2
    FF-10832 Gemcitabine Liposome Injection, 12 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
    Intervention: Drug: FF-10832 Gemcitabine Liposome Injection
  • Experimental: Cohort 6: Treatment at 17 mg/m2
    FF-10832 Gemcitabine Liposome Injection, 17 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
    Intervention: Drug: FF-10832 Gemcitabine Liposome Injection
  • Experimental: Cohort 7: Treatment at 23 mg/m2
    FF-10832 Gemcitabine Liposome Injection, 23 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
    Intervention: Drug: FF-10832 Gemcitabine Liposome Injection
  • Experimental: Cohort 8: Treatment at 30 mg/m2
    FF-10832 Gemcitabine Liposome Injection, 30 mg/m2 administered intravenously (IV) on Days 1 and 15 of each 28-day cycle
    Intervention: Drug: FF-10832 Gemcitabine Liposome Injection
  • Experimental: Cohort 21: Treatment at 12 mg/m2
    FF-10832 Gemcitabine Liposome Injection, 12 mg/m2 administered intravenously (IV) on Days 1 and 8 of each 21-day cycle
    Intervention: Drug: FF-10832 Gemcitabine Liposome Injection
  • Experimental: Cohort 22: Treatment at 17 mg/m2
    FF-10832 Gemcitabine Liposome Injection, 17 mg/m2 administered intravenously (IV) on Days 1 and 8 of each 21-day cycle
    Intervention: Drug: FF-10832 Gemcitabine Liposome Injection
  • Experimental: Cohort 23: Treatment at 23 mg/m2
    FF-10832 Gemcitabine Liposome Injection, 23 mg/m2 administered intravenously (IV) on Days 1 and 8 of each 21-day cycle
    Intervention: Drug: FF-10832 Gemcitabine Liposome Injection
  • Experimental: Cohort 24: Treatment at 30 mg/m2
    FF-10832 Gemcitabine Liposome Injection, 30 mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle.
    Intervention: Drug: FF-10832 Gemcitabine Liposome Injection
  • Experimental: Cohort 31: Treatment at 40 mg/m2
    FF-10832 Gemcitabine Liposome Injection, 40 mg/m2 administered intravenously (IV) on Day 1 of each 28-day cycle
    Intervention: Drug: FF-10832 Gemcitabine Liposome Injection
  • Experimental: Cohort 42: Treatment at 40 mg/m2
    FF-10832 Gemcitabine Liposome Injection, 40 mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle
    Intervention: Drug: FF-10832 Gemcitabine Liposome Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 18, 2020)
126
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2018)
60
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: FPHU Study Coordinator fphucontact@fujifilm.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03440450
Other Study ID Numbers  ICMJE FF10832US101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Undecided
Responsible Party Fujifilm Pharmaceuticals U.S.A., Inc.
Study Sponsor  ICMJE Fujifilm Pharmaceuticals U.S.A., Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fujifilm Pharmaceuticals U.S.A., Inc.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP