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GS-0189 for 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

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

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 more

Side effects data

From 2014 Phase 3 trial • 519 Patients • NCT01332994

15%

Nasopharyngitis

Hypertension

Bursitis

Bronchitis

100%

80%

60%

40%

20%

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

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