Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04502706
Status:
TERMINATED
Last Update Posted:
2023-06-05
First Post:
2020-07-16
Brief Title:
Study of GS-0189 Formerly FSI-189 as Monotherapy and in Combination With Rituximab in Participants With RelapsedRefractory Non-Hodgkin Lymphoma
Sponsor:
Gilead Sciences
Organization:
Gilead Sciences
Study Overview
Official Title:
A Phase 1 Study of GS-0189 Formerly FSI-189 as Monotherapy and in Combination With Rituximab in Patients With RelapsedRefractory Non-Hodgkin Lymphoma
Status:
TERMINATED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsors decision to discontinue development of this molecule
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to determine the safety and tolerability of GS-0189 formerly FSI-189 as monotherapy and in combination with rituximab in participants with relapsedrefractory RR non-Hodgkin lymphoma NHL
Detailed Description:
The study will consist of 5 parts 1 an initial Monotherapy Dose Escalation MDE part 2 a Combination Dose Escalation CDE part 3 a Pharmacokinetic PK Evaluation part 4 an Alternate Schedule Evaluation ASE part and 5 a diffuse large B-cell lymphoma DLBCL Expansion part
Study Oversight
Has Oversight DMC:
None
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?:
None