Lymphoid Malignancies
Conditions
Keywords
chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma (HL), indolent non-Hodgkin lymphoma (iNHL), diffuse large B-cell lymphoma-activated B-cell (DLBCL-ABC), DLBCL-germinal center B-cell (GCB), mantle cell lymphoma (MCL), GS-9820, phosphatidylinositol 3-kinase (PI3K)
Brief summary
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.
Interventions
DRUGGS-9820
GS-9820 tablets containing 200 mg of GS-9820 administered orally
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose (MTD) | Up to 4 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameters of GS-9820 as measured by Cmax, Tmax, Ctrough, and AUC | Baseline to Day 29 | * Cmax is defined as the maximum concentration of drug * Tmax is defined as the time of Cmax * Ctrough is defined as the trough concentration * AUC is defined as the area under the plasma concentration versus time curve |
| Pharmacodynamics to measure changes in the phosphatidylinositol 3-kinase (P13K) delta pathway activation and changes in plasma concentration of disease-associated chemokines and cytokines | Baseline to Day 29 | — |
| Overall safety | Up to 5 years | Overall safety will be assessed by overall safety profile, enumeration and description of any dose-limiting toxicities, serious adverse events, or adverse events leading to discontinuation of study drug. |
| Patient well-being assessed using changes in baseline in HRQL (health related quality of life questionnaire) domain and symptom scores based on the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym) | Up to 5 years | — |
| Drug exposure | Up to 5 years | Drug administration for GS-9820 as assessed by prescribing records and GS-9820 compliance as assessed by quantification of used and unused drug. |
| Tumor control | Up to 5 years | Tumor control as assessed by overall response rate (ORR), time to response (TTR), duration of response (DOR), progression-free survival (PFS), percent change in lymph node area, lymph node response rate, splenomegaly response rate, ALC response rate, hepatomegaly response rate, platelet response rate, hemoglobin response rate, and neutrophil response rate. |
Countries
Netherlands
Outcome results
None listed