Therapy Detail
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| Therapy Name | Idelalisib |
| Synonyms | |
| Therapy Description |
Zydelig (idelalisib) inhibits PI3K-delta, preventing the activation of the PI3K signaling pathway and inhibiting tumor cell proliferation, motility, and survival (PMID: 24450857). Zydelig (idelalisib) is FDA approved for follicular B-cell non-Hodgkin lymphoma, relapsed small lymphocytic lymphoma, and in combination with Rituxan (rituximab) for relapsed chronic lymphocytic leukemia (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Idelalisib | Zydelig | CAL-101|GS-1101 | PIK3CD inhibitor 24 | Zydelig (idelalisib) inhibits PI3K-delta, preventing the activation of the PI3K signaling pathway and inhibiting tumor cell proliferation, motility, and survival (PMID: 24450857). Zydelig (idelalisib) is FDA approved for follicular B-cell non-Hodgkin lymphoma, relapsed small lymphocytic lymphoma, and in combination with Rituxan (rituximab) for relapsed chronic lymphocytic leukemia (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| Unknown unknown | follicular lymphoma | not applicable | Idelalisib | FDA approved | Actionable | In a Phase II trial that supported FDA approval, Zydelig (idelalisib) treatment resulted in an overall response rate of 54% (39/72, 6 complete response, 33 partial response) in patients with relapsed follicular lymphoma (PMID: 24450858; NCT01282424). | 24450858 detail... |
| Unknown unknown | lymphoplasmacytic lymphoma | not applicable | Idelalisib | Phase II | Actionable | In a Phase II trial, Zydelig (idelalisib) treatment resulted in an overall response rate of 80% (8/10) in patients with lymphoplasmacytic lymphoma (PMID: 24450858; NCT01282424). | 24450858 |
| PIK3CA Q1033R PIK3CA H1047R | Burkitt lymphoma | predicted - sensitive | Idelalisib | Case Reports/Case Series | Actionable | In a clinical case study, Zydelig (idelalisib) treatment resulted in tumor shrinkage and decreased plasma LDH that continued for 10 months before recurrence in a patient with relapsed Burkitt lymphoma harboring PIK3CA H1047R and PIK3CA Q1033R (PMID: 32193631). | 32193631 |
| Unknown unknown | CLL/SLL | not applicable | Idelalisib | FDA approved | Actionable | In a Phase II trial that supported FDA approval, Zydelig (idelalisib) treatment resulted in an overall response rate of 58% (15/26, all partial response) in patients with relapsed small lymphocytic lymphoma, with a median duration of response of 11.9 months (PMID: 24450858; NCT01282424). | 24450858 detail... |
| BRAF V600E/K PIK3CA wild-type | melanoma | no benefit | Idelalisib | Preclinical | Actionable | In a preclinical study, Zydelig (idelalisib) did not inhibit proliferation of melanoma cell lines harboring BRAF V600E/K and wild-type PIK3CA in culture (PMID: 26137449). | 26137449 |
| Unknown unknown | Hodgkin's lymphoma | not applicable | Idelalisib | Phase II | Actionable | In a Phase II trial, Idelalisib treatment resulted in an overall response rate of 20% (5/25) in Hodgkin's lymphoma patients, with one patient experiencing a complete response and four patients experiencing a partial response (PMID: 28327905). | 28327905 |
| Unknown unknown | chronic lymphocytic leukemia | not applicable | Idelalisib | Preclinical - Cell culture | Actionable | In a preclinical study, Zydelig (idelalisib) inhibited proliferation, however, also resulted in increased activation-induced cytidine deaminase (AID) expression and genomic instability in a chronic lymphocytic leukemia cell line in culture (PMID: 28199309). | 28199309 |
| Unknown unknown | marginal zone B-cell lymphoma | not applicable | Idelalisib | Phase II | Actionable | In a Phase II trial, Zydelig (idelalisib) treatment resulted in an overall response rate of 47% (7/15) in patients with marginal zone B-cell lymphoma (PMID: 24450858; NCT01282424). | 24450858 |
| Unknown unknown | hematologic cancer | not applicable | Idelalisib | Phase I | Actionable | In a Phase I trial, Zydelig (idelalisib) treatment of patients with hematological malignancies produced an overall response rate of 72% (39/54) (PMID: 24615777). | 24615777 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03151057 | Phase I | Idelalisib | Idelalisib Post Allogeneic Hematopoietic Stem Cell Transplant (HSCT) in B Cell Derived Malignancies | Active, not recruiting | USA | 0 |
| NCT03133221 | Phase II | Idelalisib | 1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation | Recruiting | USA | 0 |
| NCT01732926 | Phase III | Idelalisib Bendamustine + Rituximab | Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas | Terminated | USA | CAN | 13 |
| NCT02536300 | Phase III | Idelalisib | Dose Optimization Study of Idelalisib in Follicular Lymphoma | Recruiting | USA | CAN | 9 |
| NCT03126019 | Phase II | Parsaclisib Idelalisib | An Open-Label, Randomized Study Comparing INCB050465 to Idelalisib in Relapsed or Refractory Follicular Lymphoma (CITADEL-203) | Active, not recruiting | USA | CAN | 11 |
| NCT01306643 | Phase Ib/II | Idelalisib | Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma | Completed | USA | 0 |
| NCT01732913 | Phase III | Idelalisib Rituximab | Efficacy and Safety of Idelalisib (GS-1101) in Combination With Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas | Terminated | USA | 18 |
| NCT02662296 | Phase II | Idelalisib Ibrutinib | Ibrutinib or Idelalisib in Treating Patients With Persistent or Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma After Donor Stem Cell Transplant | Withdrawn | USA | 0 |
| NCT03878524 | Phase I | Oxaliplatin Palbociclib Vemurafenib Sirolimus Tretinoin Celecoxib Ipilimumab Ruxolitinib Dasatinib Abiraterone Idelalisib Trametinib Imatinib Erlotinib Carboplatin Olaparib Panobinostat Bortezomib Afatinib Fluorouracil Vorinostat Pembrolizumab Leucovorin Enzalutamide Ponatinib Nivolumab Everolimus Sunitinib Cabazitaxel Cabozantinib Lenvatinib Pertuzumab Sorafenib Venetoclax Bevacizumab | A Personalized Medicine Study for Patients With Advanced Cancer of the Breast, Prostate, Pancreas or Those With Refractory Acute Myelogenous Leukemia (SMMART) | Recruiting | USA | 0 |
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