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GS-9820

Phase 1

Lymphoid Malignancies | Small molecule | Hematology |Gilead Sciences, Inc.|Last Updated: May 17, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

GS-9820 · 1 trial · 1 indication

Phase 1 1
NCT01705847A Phase 1b Study Evaluating GS-9820 in Subjects With Lymphoid MalignanciesLymphoid Malignancies
COMPLETED39 Analytics
PHASE1COMPLETED
A Phase 1b Study Evaluating GS-9820 in Subjects With Lymphoid Malignancies
Lymphoid MalignanciesUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Overall safety
Up to 5 years
Pharmacokinetic parameters of GS-9820 as measured by Cmax, Tmax, Ctrough, and AUC
Baseline to Day 29
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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GS-9820EXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
GS-9820DRUGGS-9820 tablets containing 200 mg of GS-9820 administered orally
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

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 ...

Countries:Netherlands
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Frequently asked questions about GS-9820

What is GS-9820 used for?

GS-9820 is an investigational small molecule being studied for the treatment of lymphoid malignancies, a group of blood cancers that affect the lymphatic system. It is currently in Phase 1 clinical development and has not been approved for any use.

Who makes GS-9820?

GS-9820 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The drug is currently in Phase 1 clinical development for lymphoid malignancies.

What phase is GS-9820 in?

GS-9820 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1b study evaluating the drug in subjects with lymphoid malignancies has been completed.

What clinical trials is GS-9820 in?

GS-9820 has been studied in one completed clinical trial, NCT01705847, a Phase 1b study evaluating the drug in subjects with lymphoid malignancies. The trial enrolled 39 participants in the Netherlands and was not randomized or blinded.

Is GS-9820 the same as any other drug?

No alternative names for GS-9820 have been disclosed. The drug is identified by its code name GS-9820 and is being developed by Gilead Sciences for lymphoid malignancies.