Trials / Terminated
TerminatedNCT04502706
Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Participants With Relapsed/Refractory Non-Hodgkin Lymphoma
A Phase 1 Study of GS-0189 (Formerly FSI-189) as Monotherapy and in Combination With Rituximab in Patients With Relapsed/Refractory Non-Hodgkin Lymphoma
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 relapsed/refractory (R/R) 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GS-0189 | GS-0189 will be administered intravenously. |
| DRUG | Rituximab | Rituximab will be administered intravenously. |
Timeline
- Start date
- 2020-11-17
- Primary completion
- 2022-03-31
- Completion
- 2022-03-31
- First posted
- 2020-08-06
- Last updated
- 2023-06-05
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04502706. Inclusion in this directory is not an endorsement.