Clinical trials: Ribociclib
CNS Embryonal Tumor, Not Otherwise Specified, Malignant Glioma
Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors
This phase I trial studies the side effects and best dose of ribociclib and everolimus and to see how well they work in treating patients with malignant brain tumors that have come back or do not respond to treatment.
- Conditions
- CNS Embryonal Tumor, Not Otherwise Specified, Malignant Glioma, Recurrent Atypical Teratoid/Rhabdoid Tumor, Recurrent Childhood Ependymoma
- Trial name
- NCT03387020
- Testing
- Everolimus, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 12 sites in United States
- Volunteers
- 22 people
- Sponsor
- Pediatric Brain Tumor Consortium
Malignant Rhabdoid Tumors (MRT), Neuroblastoma
Study of Safety and Efficacy in Patients With Malignant Rhabdoid Tumors (MRT) and Neuroblastoma
LEE011 is a small molecule inhibitor of CDK4/6. LEE011 has demonstrated in vitro and in vivo activity in both tumor models. The primary purpose of this study was to determine the maximum tolerated dose (MTD) and/or recommended…
- Trial name
- NCT01747876
- Testing
- LEE011
- Where
- 13 sites in United States, Australia and 3 more
- Volunteers
- 32 people
- Sponsor
- Novartis Pharmaceuticals
Teratoma
A Randomized, Blinded, Placebo-controlled, Phase II Trial of LEE011 in Patients With Relapsed, Refractory, Incurable Teratoma With Recent Progression
This was a multi-center, randomized, double blind (investigator and subject), placebo controlled Phase II study to determine the efficacy and safety of treatment with ribociclib versus placebo in subjects with progressive…
- Trial name
- NCT02300987
- Testing
- LEE011
- Where
- 7 sites in United States, France and 2 more
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
Neuroblastoma, Cancer
Next Generation Personalized Neuroblastoma Therapy
The purpose of this research study is to match genomic aberrations in tumor cells at time of relapse to rationally designed combinations of molecularly targeted agents.
- Trial name
- NEPENTHE (NCT02780128)
- Testing
- Biopsy, Next Generation Sequencing, Tumor Scans
- Where
- United States
- Volunteers
- 66 people
- Sponsor
- Yael P Mosse
Metastatic Breast Cancer, ER Positive Breast Cancer
To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer
This is a multi-center biomarkers study aiming to prospectively collect biological samples from patients with ER+ and HER2-negative metastatic breast cancer, who are candidate to first-line treatment with an aromatase inhibitor…
- Conditions
- Metastatic Breast Cancer, ER Positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- TIRESIAS (NCT04660435)
- Testing
- Thymidine kinase activity
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Fondazione Sandro Pitigliani
Diffuse Intrinsic Pontine Glioma, Malignant Glioma of Brain
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)
In this research study, we want to learn about the safety of the study drugs, ribociclib and everolimus, when given together at different doses after radiation therapy.
- Conditions
- Diffuse Intrinsic Pontine Glioma, Malignant Glioma of Brain, High Grade Glioma, Bithalamic High Grade Glioma
- Trial name
- NCT03355794
- Testing
- ribociclib, Everolimus
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Advanced Soft Tissue Sarcoma, Locally Advanced Angiosarcoma
Ribociclib and Doxorubicin in Treating Patients With Metastatic or Advanced Soft Tissue Sarcomas That Cannot Be Removed by Surgery
This phase Ib trial studies the side effects and best dose of ribociclib when giving together with doxorubicin hydrochloride in treating patients with soft tissue sarcomas that has spread to other places or that cannot be removed…
- Conditions
- Advanced Soft Tissue Sarcoma, Locally Advanced Angiosarcoma, Locally Advanced Leiomyosarcoma, Locally Advanced Liposarcoma
- Trial name
- NCT03009201
- Testing
- Doxorubicin Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- OHSU Knight Cancer Institute
High Grade Glioma, Diffuse Intrinsic Pontine Glioma
A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy
In this research study the investigators want to learn more about the effects, both good and bad, when the study drug Ribociclib is given after radiation therapy.
- Conditions
- High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Bithalamic High Grade Glioma
- Trial name
- NCT02607124
- Testing
- Ribociclib
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Acute Lymphoblastic Leukemia ALL
Ribociclib in Combination With Everolimus and Dexamethasone in Relapsed ALL
This research study is evaluating a drug called ribociclib (LEE011) given in combination with everolimus and other standard of care chemotherapy drugs as a possible treatment for relapsed or refractory ALL.
- Trial name
- NCT03740334
- Testing
- Ribociclib, Dexamethasone, Everolimus
- Where
- 12 sites in United States
- Volunteers
- 45 people
- Sponsor
- Dana-Farber Cancer Institute
Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8, Metastatic Breast Carcinoma
Stereotactic Radiosurgery With Abemaciclib, Ribociclib, or Palbociclib in Treating Patients With Hormone Receptor Positive Breast Cancer With Brain Metastases
This phase I trial studies the side effects of stereotactic radiosurgery with abemaciclib, ribociclib, or palbociclib in treating patients with hormone receptor positive breast cancer that has spread to the brain (brain…
- Conditions
- Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Brain, Prognostic Stage IV Breast Cancer AJCC v8
- Trial name
- NCT04585724
- Testing
- Abemaciclib, Palbociclib, Quality-of-Life Assessment
- Sponsor
- Emory University
Continued Access to Study Treatment(s), Cancers With a Mass, Bulky Tumor, Nodule, Lump, Advanced Cancer, Advanced Solid Tumors, Advanced Solid Malignancies
Ribociclib (LEE011) Rollover Study for Continued Access
This study is to allow continued use of ribociclib (LEE011) as single agent or in combination with other investigational treatments in patients benefitting from treatment in an eligible Novartis-sponsored ribociclib (LEE011)…
- Trial name
- NCT02934568
- Testing
- LEE011
- Where
- 13 sites in United States, France and 4 more
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Neuroblastoma
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
This is a Phase I/II study to assess the efficacy and safety of ribociclib in combination with topotecan and temozolomide (TOTEM) in pediatric patients with relapsed or refractory (r/r) neuroblastoma (NB), and other solid tumors…
- Trial name
- NCT05429502
- Testing
- Topotecan, Temozolomide, Ribociclib
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals
High Grade Glioma, Diffuse Intrinsic Pontine Glioma
Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant
The goal of this study is to determine the efficacy of the 1) ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in…
- Conditions
- High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Anaplastic Astrocytoma, Glioblastoma
- Trial name
- NCT05843253
- Testing
- Ribociclib, Everolimus, Temozolomide (TMZ)
- Where
- 20 sites in United States, Australia and 4 more
- Volunteers
- 120 people
- Sponsor
- Nationwide Children's Hospital