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TGR-1202+ Obinutuzumab+ Chlorambucil

Phase 1

Chronic Lymphocytic Leukemia | Small molecule | Oncology |TG Therapeutics, Inc.|Last Updated: Oct 2, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

TGR-1202+ Obinutuzumab+ Chlorambucil · 1 trial · 1 indication

Phase 1 1
NCT02100852TGR-1202, a PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)Chronic Lymphocytic Leukemia
COMPLETED19 Analytics
PHASE1COMPLETED
TGR-1202, a PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
Chronic Lymphocytic LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Tolerated Dose acceptable for participants
28 days (1 cycle of therapy)

To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

Secondary Endpoints

Overall Response Rate
Up to 1 year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TGR-1202 + Obinutuzumab + ChlorambucilEXPERIMENTALTGR-1202 is an oral daily dose with obinutuzumab at a fixed IV infusion and chlorambucil as an oral dose on specified days.

Interventions

NameTypeDescription
TGR-1202 + Obinutuzumab + ChlorambucilDRUGTGR-1202: Oral dose Obinutuzumab: IV infusion Chlorambucil: Oral dose
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Confirmed Chronic Lymphocytic Leukemia (CLL) * Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 * Ability to swallow oral medication Exclusion Criteria: * Known hepatitis B virus, hepatitis C virus or HIV infection * Primary central nervous system lymphoma or known ...

Countries:United States
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Frequently asked questions about TGR-1202+ Obinutuzumab+ Chlorambucil

What is TGR-1202 used for?

TGR-1202 is an investigational small molecule being studied for the treatment of hematologic malignancies and solid tumors. In clinical trials, it has been evaluated in patients with Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, and Pancreatic Cancer, among other conditions.

What does TGR-1202 target?

TGR-1202 is a PI3K delta inhibitor. It targets the delta isoform of phosphoinositide 3-kinase, an enzyme involved in cell growth and survival that is often overactive in certain cancers. By inhibiting this target, TGR-1202 aims to disrupt cancer cell proliferation.

Who makes TGR-1202?

TGR-1202 is being developed by TG Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol TGTX on the NASDAQ exchange.

What phase is TGR-1202 in?

TGR-1202 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. All completed trials for TGR-1202 were Phase 1 studies, and the drug remains in early-stage clinical testing.

What clinical trials is TGR-1202 in?

TGR-1202 has been studied in several completed Phase 1 trials. These include NCT01767766 in relapsed or refractory hematologic malignancies, NCT02164006 in combination with brentuximab vedotin for Hodgkin's Lymphoma, NCT02268851 with ibrutinib in CLL or MCL, and NCT02574663 in solid tumors.

Is TGR-1202 the same as umbralisib?

Yes, TGR-1202 is also known as umbralisib. The drug has been referred to by both names in clinical research and development contexts. This alternative name is used interchangeably with TGR-1202 in scientific literature and trial documentation.