Missing content? – Request curation!
Request curation for specific Genes, Variants, or PubMed publications.
Have questions, comments, or suggestions? - Let us know!
Email us at : ckbsupport@genomenon.com
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). |
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). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
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 |
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 | Terminated | USA | 0 |
NCT02612311 | Phase III | Ublituximab Chlorambucil + Obinutuzumab Umbralisib | Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia | Terminated | USA | POL | ITA | ISR | GBR | ESP | 1 |
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 |
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 |
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 |
NCT01767766 | Phase I | Umbralisib | Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies | 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 | SVK | POL | ITA | ISR | GBR | ESP | AUS | 1 |