Therapy Detail

Therapy Name Umbralisib
Synonyms
Therapy Description

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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)).

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  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

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

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Clinical Trial Phase Therapies Title Recruitment Status
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
NCT03178201 Phase II Umbralisib TGR1202 in Relapsed and Refractory Follicular Lymphoma Recruiting
NCT02164006 Phase I Umbralisib Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma Patients 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
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 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
NCT02612311 Phase III Ublituximab Chlorambucil + Obinutuzumab 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
NCT01767766 Phase I Umbralisib Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies Active, not recruiting


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