Therapy Detail

Therapy Name Umbralisib
Therapy Description

Umbralisib (TGR-1202) is a selective inhibitor of PIK3CD, which prevents Akt phosphorylation and induces cytotoxicity (J Clin Oncol 32:5s, 2014 (suppl; abstr 2513)).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Umbralisib RP5264|TGR-1202 PIK3CD inhibitor 24 Umbralisib (TGR-1202) is a selective inhibitor of PIK3CD, which prevents Akt phosphorylation and induces cytotoxicity (J Clin Oncol 32:5s, 2014 (suppl; abstr 2513)).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown hematologic cancer not applicable Umbralisib Phase I Actionable In a Phase I trial, Umbralisib (TGR-1202) demonstrated safety in patients with advanced hematological malignancies and preliminary efficacy in patients with chronic lymphocytic leukemia and non-Hodgkin's lymphoma (J Clin Oncol (Meeting Abstracts) 2015 33: 7069). detail...
Unknown unknown hematologic cancer not applicable Umbralisib Phase I Actionable In a Phase I trial, Umbralisib (TGR-1202) treatment resulted in disease burden reduction in 73% (53/73), complete response in 4% (3/73), and partial response in 41% (30/73) of patients with chronic lymphocytic leukemia and lymphoma (PMID: 29475723; NCT01767766). 29475723
Unknown unknown non-Hodgkin lymphoma not applicable Umbralisib Phase I Actionable In a Phase I trial, Umbralisib (TGR-1202) treatment resulted in complete response in 11% (1/9) and stable disease in 44% (4/9) of patients with non-Hodgkin lymphoma (PMID: 29475723; NCT01767766). 29475723
Unknown unknown mantle cell lymphoma not applicable Umbralisib Phase I Actionable In a Phase I trial, Umbralisib (TGR-1202) treatment resulted in partial response in 17% (1/6) and stable disease in 67% (4/6) of patients with mantle cell lymphoma (PMID: 29475723; NCT01767766). 29475723
Unknown unknown marginal zone B-cell lymphoma not applicable Umbralisib Phase I Actionable In a Phase I trial, Umbralisib (TGR-1202) treatment resulted in partial response in 20% (1/5) and stable disease in 80% (4/5) of patients with marginal zone B-cell lymphoma (PMID: 29475723; NCT01767766). 29475723
Unknown unknown chronic lymphocytic leukemia not applicable Umbralisib Phase II Actionable In a Phase I trial, Umbralisib (TGR-1202) treatment demonstrated safety and preliminary efficacy, with 90% of chronic lymphocytic leukemia patients achieved progression-free survival at 6.5 months (J Clin Oncol 36, 2018 (suppl; abstr 7530); NCT02742090). detail...
Unknown unknown chronic lymphocytic leukemia not applicable Umbralisib Phase I Actionable In a Phase I trial, Umbralisib (TGR-1202) treatment resulted in objective response in 85% (17/20) and stable disease in 15% (3/20) of patients with chronic lymphocytic leukemia (PMID: 29475723; NCT01767766). 29475723
Unknown unknown diffuse large B-cell lymphoma not applicable Umbralisib Phase I Actionable In a Phase I trial, Umbralisib (TGR-1202) treatment resulted in objective response in 31% (4/13) and stable disease in 15% (2/13) of patients with diffuse large B-cell lymphoma (PMID: 29475723; NCT01767766). 29475723
Unknown unknown follicular lymphoma not applicable Umbralisib Phase I Actionable In a Phase I trial, Umbralisib (TGR-1202) treatment resulted in complete response in 12% (2/17) and partial response in 41% (7/17) of patients with follicular lymphoma (PMID: 29475723; NCT01767766). 29475723
Unknown unknown Waldenstroem's macroglobulinemia not applicable Umbralisib Phase I Actionable In a Phase I trial, Umbralisib (TGR-1202) treatment resulted in stable disease in 2 patients with Waldenstroem's macroglobulinemia (PMID: 29475723; NCT01767766). 29475723
Clinical Trial Phase Therapies Title Recruitment Status
NCT03178201 Phase II Umbralisib TGR1202 in Relapsed and Refractory Follicular Lymphoma Recruiting
NCT02574663 Phase I Nab-paclitaxel + Gemcitabine 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 Active, not recruiting
NCT03364231 Phase II Umbralisib Study to Assess the Efficacy and Safety of Umbralisib in Patients With Non-Follicular Indolent Non-Hodgkin's Lymphoma Recruiting
NCT02742090 Phase II Umbralisib Evaluate the Efficacy and Safety of TGR-1202 in Patients With Chronic Lymphocytic Leukemia Who Are Intolerant to Prior Therapy Active, not recruiting
NCT02164006 Phase I Umbralisib Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma Patients Active, not recruiting
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 Enrolling by invitation
NCT01767766 Phase I Umbralisib Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies Active, not recruiting
NCT02612311 Phase III Ublituximab Obinutuzumab + Chlorambucil Umbralisib Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia Active, not recruiting
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) Recruiting