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Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma
Phase 1
Waitlist Available
Research Sponsored by Gilead Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug, GS-0189, alone and with rituximab in patients whose non-Hodgkin lymphoma has returned or didn't respond to treatment. The goal is to see if these treatments are safe and effective.
Eligible Conditions
- Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Secondary study objectives
Duration of Response (DOR)
Objective response rate (ORR)
Overall Survival (OS)
+8 moreSide effects data
From 2014 Phase 3 trial • 519 Patients • NCT0133299415%
Nasopharyngitis
6%
Hypertension
1%
Bursitis
1%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
TCZ/TCZ or TCZ/RTX
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: GS-0189 + Rituximab (Pharmacokinetic (PK) Evaluation)Experimental Treatment2 Interventions
R/R NHL participants will receive GS-0189 dose of up to 30 mg followed by the highest designated safe dose from the Combination Dose Escalation cohort (CDE) in combination with rituximab at 375 mg/m\^2.
Group II: GS-0189 + Rituximab (DLBCL Expansion)Experimental Treatment2 Interventions
Diffuse large B-cell lymphoma (DLBCL) participants will receive GS-0189 in combination with rituximab 375 mg/m\^2. The GS-0189 dose will be determined based on the totality of safety, PK, and PD data from the preceding cohorts.
Group III: GS-0189 + Rituximab (Combination Dose Escalation, CDE)Experimental Treatment2 Interventions
R/R NHL participants will receive GS-0189 doses of 100, 300, 1000, 2000, and 3000 mg in combination with rituximab at 375 mg/m\^2.
Group IV: GS-0189 + Rituximab (Alternate Schedule Evaluation, ASE)Experimental Treatment2 Interventions
R/R NHL participants will receive GS-0189 every 4 weeks in combination with rituximab 375 mg/m\^2. The GS-0189 dose will be determined based on the totality of safety, PK, and pharmacodynamic (PD) data from the preceding cohorts.
Group V: GS-0189 (Monotherapy Dose Escalation, MDE)Experimental Treatment1 Intervention
Relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL) participants will receive GS-0189 doses of 10, 30, or 100 mg every 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~2990
Find a Location
Who is running the clinical trial?
Gilead SciencesLead Sponsor
1,135 Previous Clinical Trials
868,027 Total Patients Enrolled
44 Trials studying Lymphoma
3,259 Patients Enrolled for Lymphoma
Gilead Study DirectorStudy DirectorGilead Sciences
360 Previous Clinical Trials
192,478 Total Patients Enrolled
18 Trials studying Lymphoma
2,347 Patients Enrolled for Lymphoma