Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-30 @ 8:21 AM
Study NCT ID:
NCT03440450
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-18
First Post:
2018-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer
Sponsor:
Fujifilm Pharmaceuticals U.S.A., Inc.
Organization:
Study Overview
Official Title:
A Phase 1 Dose-escalation Study of FF-10832 for the Treatment of Advanced Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 including biliary tract cancer
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 18 patients in a 21 day cycle.
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 18 patients in a 21 day cycle.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: