15 completed, 7 active not recruiting, 6 terminated, 2 unknown. 31 Phase 2, 11 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 31 | Completed 15, Active not recruiting 7, Terminated 6, Unknown 2, Recruiting 1 |
| Phase 1 | 11 | Terminated 4, Active not recruiting 3, Completed 3, Recruiting 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 |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| A Phase II, Two-Arm Study of Everolimus and Letrozole, +/- Ribociclib (Lee011) in Patients With Advanced or Recurrent Endometrial Carcinoma Everolimus, Letrozole, Ribociclib - Recurrent Endometrial Carcinoma, Recurrent Endometrial Endometrioid Adenocarcinoma | Phase 2 | Active not recruiting | M.D. Anderson Cancer Center | 90 | 2017-08-18 | 2026-05-22 |
| Phase II Trial of Ribociclib and Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS) Ribociclib, Everolimus - Soft Tissue Sarcoma | Phase 2 | Active not recruiting | Fox Chase Cancer Center | 48 | 2017-08-08 | 2026-05-22 |
| Neadjuvant Multi-agent Chemotherapy or Letrozole Plus Ribociclib in Luminal B/HER2-negative Breast Cancer. Ribociclib, Letrozole 2.5mg, Doxorubicin - Breast Cancer | Phase 2 | Completed | SOLTI Breast Cancer Research Group | 106 | 2017-07-13 | 2021-03-17 |
| Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer Ribociclib, Adjuvant endocrine therapy, Placebo - Breast Cancer | Phase 2 | Completed | Novartis Pharmaceuticals | 54 | 2017-06-20 | 2021-10-11 |
| LEE011 Plus Everolimus in Patients With Metastatic Pancreatic Adenocarcinoma Refractory to Chemotherapy LEE011, Everolimus - Metastatic Pancreatic Adenocarcinoma | Phase 1 / Phase 2 | Completed | Georgetown University | 12 | 2017-05-04 | 2026-04-07 |
| A Study of LEE011 With Everolimus in Patients With Advanced Neuroendocrine Tumors LEE011, everolimus - Neuroendocrine Tumors | Phase 2 | Completed | Memorial Sloan Kettering Cancer Center | 21 | 2017-02-27 | 2024-10-10 |
| Ribociclib (LEE011) Rollover Study for Continued Access LEE011 - Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies | Phase 2 | Active not recruiting | Novartis Pharmaceuticals | 22 | 2016-12-15 | 2026-04-16 |
| European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors Ribociclib, Topotecan, Temozolomide - Pediatric Cancer | Phase 1 / Phase 2 | Recruiting | Gustave Roussy, Cancer Campus, Grand Paris | 472 | 2016-08-03 | 2026-07-10 |
| Ribociclib and Letrozole in Treating Patients With Relapsed ER Positive Ovarian, Fallopian Tube, Primary Peritoneal, or Endometrial Cancer Laboratory Biomarker Analysis, Letrozole, Ribociclib - Estrogen Receptor Positive, Postmenopausal | Phase 2 | Completed | Mayo Clinic | 40 | 2016-07-08 | 2021-10-26 |
| A Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well/Dedifferentiated Liposarcoma Ribociclib - Liposarcomas, Dedifferentiated, Liposarcoma - Well Differentiated | Phase 2 | Unknown | Assaf-Harofeh Medical Center | 30 | 2016-07-01 | 2017-10-25 |
| A Phase II Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well/Dedifferentiated Liposarcoma ribociclib - Liposarcoma, Soft Tissue Sarcoma | Phase 2 | Unknown | Hadassah Medical Organization | 30 | 2016-05-01 | 2016-11-23 |
| A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy Ribociclib - High Grade Glioma, Diffuse Intrinsic Pontine Glioma | Phase 1 / Phase 2 | Terminated | Children's Hospital Medical Center, Cincinnati | 11 | 2016-04-01 | 2020-11-05 |
Showing 20 of 31. Sign in to see all of them.
Breast Neoplasms (8) · Liposarcoma (3) · Melanoma (3) · Sarcoma (3) · Neoplasms (2) · Ovarian Neoplasms (2) · Carcinoma, Hepatocellular (1) · Carcinoma, Non-Small-Cell Lung (1) · Colorectal Neoplasms (1) · Diffuse Intrinsic Pontine Glioma (1) · Endometrial Neoplasms (1) · Fallopian Tube Neoplasms (1) · Glioma (1) · Hematologic Neoplasms (1) · Leiomyosarcoma (1)
Novartis Pharmaceuticals (9) · M.D. Anderson Cancer Center (3) · Pfizer (3) · Array BioPharma (1) · Assaf-Harofeh Medical Center (1) · Children's Hospital Medical Center, Cincinnati (1) · City of Hope Medical Center (1) · Fox Chase Cancer Center (1) · Georgetown University (1) · Gustave Roussy, Cancer Campus, Grand Paris (1) · Hadassah Medical Organization (1) · Jonsson Comprehensive Cancer Center (1) · Kari Wisinski (1) · Mayo Clinic (1) · Memorial Sloan Kettering Cancer Center (1)
United States (26) · Spain (9) · France (8) · Italy (7) · Australia (6) · Germany (6) · Netherlands (6) · Canada (5) · Switzerland (4) · United Kingdom (4) · Belgium (3) · Singapore (3) · Israel (2) · South Korea (2) · Argentina (1)
Aleix Prat, PhD (1) · Array BioPharma (1) · Benjamin Weinberg, MD (1) · Birgit Geoerger, MD (1) · Daniela Katz, M.D (1) · Daniela Katz, MD (1) · Diane Reidy-Lagunes, MD, MS (1) · Gerardo Colon-Otero (1) · Kari Wisinski, MD (1) · Margaret von Mehren, MD (1) · Mariko DeWire, MD (1) · Mina Sedrak, MD (1)
PMID 42334791, PMID 17513820, PMID 31538815, PMID 31838010, PMID 32354716, PMID 32669376, PMID 33034839, PMID 33109627, PMID 33640871, PMID 33892407, PMID 34347542, PMID 34376578, PMID 34543871, PMID 35292802, PMID 35294522, PMID 36067616, PMID 36800111, PMID 40996770, PMID 41838385, PMID 41914670, PMID 42686334, PMID 42823426
2014 (2), 2018 (2), 2023 (2), 2016 (1), P30CA015083 (1), P30CA016672 (1)