Therapy Detail

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Therapy Name Umbralisib
Synonyms
Therapy Description

Ukoniq (umbralisib) is a selective inhibitor of PIK3CD, which prevents Akt phosphorylation and induces cytotoxicity (J Clin Oncol 32:5s, 2014 (suppl; abstr 2513), PMID: 30709431). Ukoniq (umbralisib) is FDA approved for use in adult patients with relapsed or refractory marginal zone lymphoma with one or more prior anti-CD20-based therapy, and in adult patients with relapsed or refractory follicular lymphoma who have three or more prior lines of therapy (FDA.gov).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Umbralisib Ukoniq RP5264|TGR-1202 PIK3CD inhibitor 27 Ukoniq (umbralisib) is a selective inhibitor of PIK3CD, which prevents Akt phosphorylation and induces cytotoxicity (J Clin Oncol 32:5s, 2014 (suppl; abstr 2513), PMID: 30709431). Ukoniq (umbralisib) is FDA approved for use in adult patients with relapsed or refractory marginal zone lymphoma with one or more prior anti-CD20-based therapy, and in adult patients with relapsed or refractory follicular lymphoma who have three or more prior lines of therapy (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02574663 Phase I Gemcitabine + Nab-paclitaxel Bevacizumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Umbralisib TGR-1202 Alone and in Combination With Either Nab-paclitaxel + Gemcitabine or With FOLFOX in Patients With Select Relapsed or Refractory Solid Tumors Completed USA 0
NCT02793583 Phase II Umbralisib Ublituximab + Umbralisib Study to Assess the Efficacy and Safety of Ublituximab + TGR-1202 and TGR-1202 Alone in Patients With Previously Treated Diffuse Large B-Cell Lymphoma (UNITY-DLBCL) Terminated USA | ITA | GBR | ESP | AUS 4
NCT02164006 Phase I Umbralisib Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma Patients Completed USA 0
NCT03178201 Phase II Umbralisib TGR1202 in Relapsed and Refractory Follicular Lymphoma Terminated USA 0
NCT04163718 Phase II Umbralisib TGR-1202 (Umbralisib) in Treatment Naive Patients With Chronic Lymphocytic Leukemia (CLL) Terminated USA 0
NCT02742090 Phase II Umbralisib Evaluate the Efficacy and Safety of TGR-1202 in Patients With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy Completed USA 0
NCT03364231 Phase II Umbralisib Study to Assess the Efficacy and Safety of Umbralisib in Patients With Non-Follicular Indolent Non-Hodgkin's Lymphoma Completed USA 0
NCT02612311 Phase III Ublituximab Chlorambucil + Obinutuzumab Umbralisib Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia Completed USA | ITA | GBR | ESP 3
NCT03207256 Phase II Ublituximab + Umbralisib Umbralisib Compassionate Use Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials Terminated USA 0
NCT01767766 Phase I Umbralisib Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies Completed USA 0


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