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

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ClinicalTrials.gov Identifier: NCT03440450
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Fujifilm Pharmaceuticals U.S.A., Inc.

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 the first cohort, FF-10832 1.2 mg/mPP2PP will be administered intravenously (IV) on Days 1 and 15 of each 28-day cycle, 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 for the Treatment of Advanced Solid Tumors
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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 60 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 60 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 60 minutes




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.



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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


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, 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.

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Responsible Party: Fujifilm Pharmaceuticals U.S.A., Inc.
ClinicalTrials.gov Identifier: NCT03440450     History of Changes
Other Study ID Numbers: FF10832US101
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
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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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