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GS-0189 for Non-Hodgkin's 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

Study Summary

This study is evaluating whether a drug called FSI-189 may help treat non-Hodgkin lymphoma.

Eligible Conditions
  • Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Secondary outcome measures
Duration of Response (DOR)
Objective response rate (ORR)
Overall Survival (OS)
+12 more

Side effects data

From 2014 Phase 3 trial • 519 Patients • NCT01332994
15%
Nasopharyngitis
6%
Hypertension
1%
Bursitis
1%
Bronchitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
TCZ/TCZ or TCZ/RTX

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
~1880

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor
1,085 Previous Clinical Trials
848,297 Total Patients Enrolled
Gilead Study DirectorStudy DirectorGilead Sciences
343 Previous Clinical Trials
186,532 Total Patients Enrolled
~2 spots leftby Jun 2025
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