Clinical trial · Interventional
A Phase 1b Study Evaluating GS-9820 in Subjects With Lymphoid Malignancies
A Phase 1b Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GS-9820 in Subjects With Lymphoid Malignancies
NCT01705847CI-TRIAL-00022191completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to determine the appropriate dosing regimen of GS-9820 in subjects with lymphoid malignancies. This is a Phase 1b, open-label, dose-escalation and expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of GS-9820.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoid Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GS-9820 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GS-9820
- description
- Participants will be sequentially enrolled at progressively higher dose levels to receive GS-9820 administered twice a day. Escalation will proceed to the maximum tolerated dose (MTD), defined as the highest tested dose associated with a rate of dose-limiting toxicities (DLT) of \< 33% during the first 4 weeks of therapy.
- interventionNames
- Drug: GS-9820
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- Up to 4 weeks
- description
- MTD will be assessed to determine the appropriate dosing regimens for use in future clinical trials of GS-9820 in subjects with lymphoid malignancies.
Secondary outcomes (6)
- measure
- Overall safety
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previously treated recurrent B-cell iNHL, DLBCL, MCL, HL or CLL * Measurable lymphadenopathy * Requires therapy Exclusion Criteria: * Recent history of a major non-lymphoid malignancy * Evidence of ongoing infection * Concurrent participation in another therapeutic clinical trial
References
Publications (0)
Data not yet available
No reference posted for this study.