Molecular Profile Detail

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Profile Name RB1 positive
Gene Variant Detail

RB1 positive (unknown)

Relevant Treatment Approaches

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
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
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 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
Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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 Not yet 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
NCT01522989 Phase I Fluorouracil + Oxaliplatin + Palbociclib PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies 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) Recruiting USA 1
NCT03130439 Phase II Abemaciclib Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer Recruiting USA 0
NCT03781960 Phase II Abemaciclib + Nivolumab Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma Active, not recruiting USA 0
NCT04391595 Phase I Abemaciclib + LY3214996 LY3214996 Plus Abemaciclib in Recurrent Glioblastoma Patients Recruiting 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
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
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
NCT03114527 Phase II Everolimus + Ribociclib Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS) 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
NCT02030483 Phase I Palbociclib Dexamethasone Lenalidomide Palbociclib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma Terminated 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 Recruiting USA 0
NCT03535506 Phase II Palbociclib Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery (WI223281) 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
NCT02524119 Phase II Ribociclib LEE001 and Chemoembolization In Patients With Advanced Hepatocellular Carcinoma (LEE001) Terminated USA 0
NCT04040205 Phase II Abemaciclib Abemaciclib for Bone and Soft Tissue Sarcoma With Cyclin-Dependent Kinase (CDK) Pathway Alteration 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
NCT02255461 Phase I Palbociclib Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors Terminated USA 0
NCT02933736 Phase 0 Ribociclib Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients Recruiting USA 0