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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03440450
• Other study ID #: FF10832US101
• Status: Recruiting
• Phase: Phase 1
• Start date: March 22, 2018
• Est. completion date: March 2025

Study information

• Verified date: January 2024
• Source: Fujifilm Pharmaceuticals U.S.A., Inc.
• Contact: FPHU Study Coordinator
• Email: fphucontact[@]fujifilm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Sarah Cannon Research Institute	Denver	Colorado
United States	MD Anderson Cancer Research Center	Houston	Texas
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Hoag Memorial Hospital Comprehensive Cancer Center	Newport Beach	California
United States	Honor Health Research Institute	Scottsdale	Arizona
United States	Virginia Mason Medical Center	Seattle	Washington
United States	University of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Fujifilm Pharmaceuticals U.S.A., Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine incidence of Treatment Emergent Adverse Events (TEAE)	Safety and tolerability assessed by adverse events (AEs) and serious adverse events (SAEs)	2.5 years
Primary	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	2.5 years
Primary	Determine maximun tolerated dose (MTD) of FF-10832	MTD is defined as the next lower dose of a cohort where patients experienced a DLT	2.5 years
Secondary	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)	2.5 years
Secondary	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.	2.5 years
Secondary	Duration of Response	Duration of Response is calculated from the date of first response to the date of progression or death	2.5 years
Secondary	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	2.5 years
Secondary	Time to progression (TTP)	Time to progression is calculated from the date of first treatment to the date of first progression	2.5 years
Secondary	Progression-free survival (PFS)	Progression-free survival will be calculated from the date of first treatment to the date of progression or death	2.5 years
Secondary	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.	2.5 years