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

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ClinicalTrials.gov Identifier: NCT03440450
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Fujifilm Pharmaceuticals U.S.A., Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: FF-10832 Gemcitabine Liposome Injection Phase 1

Detailed Description:

Dose-escalation Phase Eligible patients will receive FF-10832 in 28 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 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
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
Official Title: A Phase 1 Dose-escalation Study of FF-10832 Monotherapy or in Combination With Nab-paclitaxel for the Treatment of Advanced Solid Tumors
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022

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Arms and Interventions
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Arm Intervention/treatment
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
 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
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
 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
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
 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
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
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440450


Contacts
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Contact: FPHU Study Coordinator fphucontact@fujifilm.com

Locations
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United States, Arizona
Honor Health Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
United States, California
Hoag Memorial Hospital Comprehensive Cancer Center Recruiting
Newport Beach, California, United States, 92658
United States, Colorado
Sarah Cannon Research Institute Recruiting
Denver, Colorado, United States, 80218
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
MD Anderson Cancer Research Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Fujifilm Pharmaceuticals U.S.A., Inc.
More Information
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Responsible Party: Fujifilm Pharmaceuticals U.S.A., Inc.
ClinicalTrials.gov Identifier: NCT03440450    
Other Study ID Numbers: FF10832US101
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fujifilm Pharmaceuticals U.S.A., Inc.:
Liposomal gemcitabine
Additional relevant MeSH terms:
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Neoplasms
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
 Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs