Ignite Creation Date:
2024-05-06 @ 3:33 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02318329
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2014-11-25
Brief Title:
Open-Label Dose-Finding Study Evaluating Safety and PK of FPA144 in Patients With Advanced Solid Tumors
Sponsor:
Five Prime Therapeutics Inc
Organization:
Five Prime Therapeutics Inc
Study Overview
Official Title:
A Phase 1 Open-Label Dose-Finding Study Evaluating Safety and Pharmacokinetics of FPA144 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2021-12
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:
This is a three-part open-label safety tolerability and PK study of FPA144 Patients will be enrolled in Part 1 A or B dose escalation or Part 2 dose expansion of the study but not both
Detailed Description:
Part 1A is a dose-escalation study in patients with any locally advanced or metastatic solid tumor or lymphoma for which standard therapies have been exhausted Part 1B will further assess safety and evaluate PK of FPA144 in gastric cancer patients
Part 2 patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in a selected cancer patient population with the greatest potential for clinical benefit from FPA144 treatment
Part 2 patients will be enrolled and treated in order to further characterize safety and preliminary efficacy in a selected cancer patient population with the greatest potential for clinical benefit from FPA144 treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None