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Profile Name | RB1 positive |
Gene Variant Detail | |
Relevant Treatment Approaches |
Molecular Profile | Indication/Tumor Type | Response Type | Relevant Treatment Approaches | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|---|
RB1 positive | Advanced Solid Tumor | sensitive | SHR6390 | Preclinical - Cell culture | Actionable | In a preclinical study, SHR6390 (dalpiciclib) inhibited CDK4/6-RB pathway signaling, leading to cell cycle arrest and inhibition of proliferation in a panel of RB1-positive tumor cell lines in culture, and tumor growth inhibition in cell line xenograft models (PMID: 30724426). | 30724426 | |
RB1 positive | Advanced Solid Tumor | predicted - sensitive | Ribociclib | Phase I | Actionable | In a Phase I clinical trial, Kisqali (ribociclib) demonstrated safety and preliminary efficacy in patients with RB1-positive solid tumors and lymphomas, resulting in partial responses in 2.3% (3/132) of patients and stable disease in 32.6% (41/132) of patients, including 8 patients demonstrating stable disease for greater than 6 months (PMID: 27542767, PMID: 24795392). | detail... 24795392 27542767 | |
RB1 positive | prostate cancer | no benefit | Palbociclib | Phase II | Actionable | In a Phase II trial, addition of Ibrance (palbociclib) to androgen deprivation therapy (ADT) did not improve the rate of PSA less or equal to 4 ng/ml at 28 weeks (80%, 32/40 vs 80%, 16/20, p=0.87), PSA undetectable rate at 28 weeks (43% vs 50%, p=0.5), radiographic response rate (89% vs 89%), or 12-month biochemical progression-free survival (74% vs 69%, p=0.72) in patients with metastatic hormone-sensitive prostate cancer expressing Rb1 as confirmed by IHC (PMID: 33727260; NCT02059213). | 33727260 | |
RB1 positive | colon cancer | sensitive | SHR6390 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, SHR6390 (dalpiciclib) inhibited CDK4/6-RB pathway activation, leading to growth inhibition in an RB1-positive colon cancer cell line in culture, and tumor regression in a cell line xenograft model (PMID: 30724426). | 30724426 | |
RB1 positive | glioblastoma | predicted - sensitive | Palbociclib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Ibrance (palbociclib) inhibited proliferation of RB1-proficient glioblastoma cell lines in culture and inhibited tumor growth in intracranial cell line xenograft models (PMID: 20354191). | 20354191 | |
RB1 positive | medulloblastoma | sensitive | Palbociclib | Preclinical - Pdx | Actionable | In a preclinical study, Ibrance (palbociclib) inhibited Rb1 phosphorylation in tumor tissues and improved survival in patient-derived intracranial xenograft models of medulloblastoma (PMID: 27012813). | 27012813 | |
RB1 positive | breast cancer | predicted - sensitive | Paclitaxel + Palbociclib | Phase I | Actionable | In a Phase I trial, alternating sequential treatment with Ibrance (palbociclib) and Taxol (paclitaxel) resulted in a median progression-free survival (mPFS) of 209 days in patients with Rb1-positive breast cancer, with a mPFS of 802 days and a clinical benefit rate of 55.6% (5/9) at the recommended phase II dose (PMID: 30635336; NCT01320592). | 30635336 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT02933736 | Phase 0 | Ribociclib | Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients | Recruiting | USA | 0 |
NCT04040205 | Phase II | Abemaciclib | Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration | Recruiting | USA | 0 |
NCT02599363 | Phase I | Paclitaxel + Ribociclib | A Trial of Ribocilcib (LEE011) and Weekly Paclitaxel in Patients With Rb+ Advanced Breast Cancer | Active, not recruiting | USA | 0 |
NCT04316169 | Phase I | Abemaciclib + Anastrozole + Hydroxychloroquine Abemaciclib + Fulvestrant + Hydroxychloroquine Abemaciclib + Hydroxychloroquine Abemaciclib + Hydroxychloroquine + Letrozole | Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer | Recruiting | USA | 0 |
NCT03155620 | Phase II | Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) | Recruiting | USA | 1 |
NCT04391595 | Phase I | Abemaciclib + LY3214996 | LY3214996 Plus Abemaciclib in Recurrent Glioblastoma Patients | Recruiting | USA | 0 |
NCT03110744 | Phase II | Palbociclib | CDK4/6 Inhibition in Locally Advanced/Metastatic Chordoma (NCT-PMO-1601) | Recruiting | DEU | 0 |
NCT02524119 | Phase II | Ribociclib | LEE001 and Chemoembolization In Patients With Advanced Hepatocellular Carcinoma (LEE001) | Terminated | USA | 0 |
NCT02255461 | Phase I | Palbociclib | Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors | Terminated | USA | 0 |
NCT03781960 | Phase II | Abemaciclib + Nivolumab | Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma | Completed | USA | 0 |
NCT02555189 | Phase Ib/II | Ribociclib Enzalutamide | Enzalutamide With and Without Ribociclib for Metastatic, Castrate-Resistant, Chemotherapy-Naive Prostate Cancer That Retains RB Expression | Recruiting | USA | 0 |
NCT02030483 | Phase I | Palbociclib Dexamethasone Lenalidomide | Palbociclib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma | Terminated | USA | 0 |
NCT03535506 | Phase II | Palbociclib | Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery (WI223281) | Recruiting | USA | 0 |
NCT03355794 | Phase I | Everolimus + Ribociclib | A Study of Ribociclib and Everolimus Following Radiation Therapy in Children With Newly Diagnosed Non-biopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High Grade Gliomas (HGG) | Active, not recruiting | USA | 0 |
NCT01522989 | Phase I | Fluorouracil + Oxaliplatin + Palbociclib | PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies | Unknown status | USA | 0 |
NCT03130439 | Phase II | Abemaciclib | Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer | Active, not recruiting | USA | 0 |
NCT03114527 | Phase II | Everolimus + Ribociclib | Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS) | Active, not recruiting | USA | 0 |
NCT03526250 | Phase II | Palbociclib | Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial) | Active, not recruiting | USA | 1 |
NCT03009201 | Phase I | Doxorubicin + Ribociclib | Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery | Active, not recruiting | USA | 0 |
NCT03834740 | Phase I | Everolimus + Ribociclib | A Phase 0 /II Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection | Active, not recruiting | USA | 0 |
NCT01356628 | Phase II | Palbociclib | A Clinical Research Study to Determine Whether PD 0332991 May Be Effective in Treating Patients With Liver Cancer | Active, not recruiting | USA | 0 |
NCT02334527 | Phase II | Palbociclib | Phase II Trial of Palbociclib (PD-0332991) in Patients With Metastatic Urothelial Cancer (UC) After Failure of First-Line Chemotherapy | Terminated | USA | 0 |