36 completed, 16 terminated, 13 active not recruiting, 3 unknown. 40 Phase 1, 31 Phase 2, 9 Phase 3, 2 Phase 4, 1 Early Phase 1.
Follow LEE011: new trials by email Literature Review of LEE011 trials Research Report on LEE011
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Phase IIIb Study of Ribociclib + ET in Early Breast Cancer Ribociclib, Letrozole, Ansastrozole - Early Breast Cancer | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 1464 | 2024-02-28 | 2026-10-23 |
| Study of Efficacy and Safety of Ribociclib (LEE011) in Combination With Topotecan and Temozolomide (TOTEM) in Pediatric Patients With Relapsed or Refractory Neuroblastoma and Other Solid Tumors Topotecan, Temozolomide, Ribociclib - Neuroblastoma | Phase 1 | Terminated | Novartis Pharmaceuticals | 12 | 2022-12-27 | 2025-10-10 |
| Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation JDQ443, trametinib, Ribociclib - KRAS G12C Mutant Solid Tumors, Carcinoma, Non-Small Cell Lung | Phase 1 / Phase 2 | Terminated | Novartis Pharmaceuticals | 74 | 2022-10-24 | 2026-10-21 |
| Roll-over Study to Allow Continued Access to Ribociclib Ribociclib, Letrozole, Anastrozole - Metastatic Breast Cancer | Phase 4 | Active not recruiting | Novartis Pharmaceuticals | 134 | 2022-07-07 | 2026-10-19 |
| The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trials Binimetinib, Encorafenib, Vemurafenib - Solid Tumors | Phase 4 | Recruiting | Pfizer | 210 | 2022-07-05 | 2026-10-19 |
| Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer Carboplatin, Docetaxel, Fulvestrant - Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8 | Phase 1 / Phase 2 | Active not recruiting | Jonsson Comprehensive Cancer Center | 18 | 2022-04-07 | 2026-05-11 |
| Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases Abemaciclib, Palbociclib, Quality-of-Life Assessment - Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8, Metastatic Breast Carcinoma | Phase 1 | Withdrawn | Emory University | 2020-06-12 | 2021-10-18 | |
| Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies TNO155, Spartalizumab, Ribociclib - Non-small Cell Lung Carcinoma, Head and Neck Squamous Cell Carcinoma | Phase 1 | Terminated | Novartis Pharmaceuticals | 122 | 2019-07-30 | 2025-09-30 |
| Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer Ribociclib, Anastrozole, Letrozole - Breast Cancer | Phase 2 | Completed | Novartis Pharmaceuticals | 376 | 2019-06-11 | 2025-10-16 |
| Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study Abemaciclib, Anastrozole, Fulvestrant - Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma | Phase 2 | Terminated | M.D. Anderson Cancer Center | 4 | 2019-05-31 | 2024-12-27 |
| Ribociclib in Combination With Everolimus and Dexamethasone in Relapsed ALL Ribociclib, Dexamethasone, Everolimus - Acute Lymphoblastic Leukemia ALL | Phase 1 | Active not recruiting | Dana-Farber Cancer Institute | 45 | 2019-01-30 | 2026-08-21 |
| A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer Ribociclib, Endocrine Therapy (ET) - Early Breast Cancer | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 5101 | 2018-12-07 | 2026-10-09 |
| Study of Efficacy and Safety of Novel Spartalizumab Combinations in Patients With Previously Treated Unresectable or Metastatic Melanoma PDR001, LAG525, INC280 - Melanoma | Phase 2 | Completed | Novartis Pharmaceuticals | 196 | 2018-09-10 | 2024-06-18 |
| Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer. Ribociclib Placebo, Ribociclib, NSAI: Letrozole or Anastrazole - Breast Cancer | Phase 2 | Completed | Novartis Pharmaceuticals | 327 | 2018-08-29 | 2026-07-08 |
| Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer Aromatase Inhibitor, Laboratory Biomarker Analysis, Pharmacokinetic Study - Estrogen Receptor and/or Progesterone Receptor Positive, HER2/Neu Negative | Phase 2 | Completed | City of Hope Medical Center | 2 | 2018-06-14 | 2024-02-20 |
| Ribociclib and Bicalutamide in AR+ TNBC ribociclib, Bicalutamide - Triple Negative Breast Cancer | Phase 1 / Phase 2 | Active not recruiting | Kari Wisinski | 37 | 2018-05-07 | 2026-01-02 |
| Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- Intermediate Risk Early Breast Cancer Ribociclib, Placebo, Adjuvant endocrine therapy - Breast Cancer | Phase 3 | Withdrawn | Novartis Pharmaceuticals | 2018-03-31 | 2018-03-15 | |
| SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors Gemcitabine, ribociclib, sonidegib - Anaplastic Astrocytoma, Anaplastic Ependymoma | Phase 1 | Completed | St. Jude Children's Research Hospital | 68 | 2018-03-05 | 2024-05-31 |
| Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant Ribociclib, Letrozole, Alpelisib - Breast Cancer | Phase 3 | Terminated | Novartis Pharmaceuticals | 287 | 2018-02-02 | 2026-07-10 |
| Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors Everolimus, Laboratory Biomarker Analysis, Pharmacological Study - CNS Embryonal Tumor, Not Otherwise Specified, Malignant Glioma | Phase 1 | Completed | Pediatric Brain Tumor Consortium | 22 | 2018-01-13 | 2021-08-27 |
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Breast Neoplasms (25) · Neoplasms (7) · Glioma (5) · Liposarcoma (5) · Sarcoma (4) · Carcinoma, Non-Small-Cell Lung (3) · Colorectal Neoplasms (3) · Glioblastoma (3) · Lymphoma (3) · Medulloblastoma (3) · Melanoma (3) · Neoplasm Metastasis (3) · Neuroblastoma (3) · Recurrence (3) · Brain Neoplasms (2)
Novartis Pharmaceuticals (36) · Pfizer (4) · M.D. Anderson Cancer Center (3) · Dana-Farber Cancer Institute (2) · Mayo Clinic (2) · Array BioPharma (1) · Assaf-Harofeh Medical Center (1) · Children's Hospital Medical Center, Cincinnati (1) · City of Hope Medical Center (1) · Cliniques universitaires Saint-Luc- Université Catholique de Louvain (1) · Emory University (1) · Fox Chase Cancer Center (1) · Georgetown University (1) · Gustave Roussy, Cancer Campus, Grand Paris (1) · H. Lee Moffitt Cancer Center and Research Institute (1)
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