Clinical trials: CDK4/6 Inhibitor
Anaplastic Astrocytoma, Anaplastic Ependymoma
SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors
Approximately 90% of children with malignant brain tumors that have recurred or relapsed after receiving conventional therapy will die of disease.
- Conditions
- Anaplastic Astrocytoma, Anaplastic Ependymoma, Anaplastic Ganglioglioma, Anaplastic Meningioma
- Trial name
- NCT03434262
- Testing
- Gemcitabine, ribociclib, sonidegib
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- St. Jude Children's Research Hospital
Ewing Sarcoma, Solid Tumors
Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults…
- Conditions
- Ewing Sarcoma, Solid Tumors, Rhabdoid Tumor, Rhabdomyosarcoma
- Trial name
- NCT03709680
- Testing
- Palbociclib, Temozolomide, Irinotecan
- Where
- 84 sites in United States, Brazil and 11 more
- Volunteers
- 128 people
- Sponsor
- Pfizer
Breast Cancer
Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer
This study is being done to answer the following question: Can testing breast cancer for DNA abnormalities or "biomarkers" help predict which patients are most likely to be helped by certain treatments? The pre-study screening is…
- Trial name
- NCT05601440
- Testing
- RP-6306, Gemcitabine, Observation
- Where
- 10 sites in Canada
- Volunteers
- 484 people
- Sponsor
- Canadian Cancer Trials Group
Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma
Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer
This phase II trial studies how well abemaciclib works in treating patients with ovarian or endometrial cancer that has an activation of the CDK4/6 pathway and that has come back (recurrent).
- Conditions
- Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
- Trial name
- NCT04469764
- Testing
- Abemaciclib, Anastrozole, Letrozole
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Jonsson Comprehensive Cancer Center
Glioma
A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy
The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy.
- Trial name
- NCT06413706
- Testing
- Abemaciclib, Temozolomide
- Where
- 37 sites in United States, Australia and 8 more
- Volunteers
- 45 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Treatment Landscape and Real-World Dosing Patterns With CDK4/6 Inhibitors for Breast Cancer in Portugal
Assess and characterize the real-world cyclin-dependent kinase 4/6 inhibitor (CDKI) use in advanced/metastatic breast cancer (a/mBC), evaluate treatment persistence, and quantify CDKI dose adjustments in Portugal.
- Trial name
- PORTRAIT (NCT07223476)
- Where
- United States
- Volunteers
- 1,926 people
- Sponsor
- Novartis Pharmaceuticals
Childhood Choroid Plexus Tumor, Childhood Ependymoblastoma
Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors
This phase I trial studies the side effects and best dose of palbociclib isethionate in treating younger patients with central nervous system tumors that have grown, come back, or not responded to treatment.
- Conditions
- Childhood Choroid Plexus Tumor, Childhood Ependymoblastoma, Childhood Grade III Meningioma, Childhood High-grade Cerebellar Astrocytoma
- Trial name
- NCT02255461
- Testing
- palbociclib isethionate, pharmacological study, laboratory biomarker analysis
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Pediatric Brain Tumor Consortium
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors
This phase I trial tests the safety, side effects, and best dose of ZEN003694 when given together with abemaciclib in treating patients with NUT carcinoma, breast cancer or other solid tumors that have spread from where it first…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Solid Neoplasm
- Trial name
- NCT05372640
- Testing
- Abemaciclib, BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure
- Where
- 7 sites in United States
- Volunteers
- 45 people
- Sponsor
- National Cancer Institute (NCI)
Ewing Sarcoma, Myelosuppression
A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using Trilaciclib
This study is a prospective, open label, randomized controlled clinical trial aimed at patients with Ewing's sarcoma who have not received systematic anti-tumor treatment in the past.
- Trial name
- NCT06699472
- Testing
- Chemotherapy, Trilaciclib Injection [Cosela]
- Where
- China
- Volunteers
- 22 people
- Sponsor
- Fudan University
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
Leukemia, Lymphocytic, Lymphoblastic Lymphoma
Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)
AINV18P1 is a Phase 1 study where palbociclib will be administrated in combination with a standard re-induction platform in pediatric relapsed Acute Lymphoblastic Leukemia (ALL) and lymphoblastic lymphoma (LL).
- Conditions
- Leukemia, Lymphocytic, Lymphoblastic Lymphoma, T-cell Lymphoma, T-cell Leukemia
- Trial name
- NCT03792256
- Testing
- Palbociclib, Cytarabine, Methotrexate
- Where
- 19 sites in United States
- Volunteers
- 12 people
- Sponsor
- Children's Oncology Group
Neurofibromatosis 1
Cyclin-Dependent Kinase (CDK)4/6 Inhibitor Abemaciclib for Neurofibromatosis Type I (NF1) Related Atypical Neurofibromas
Background: NF1 is a genetic disease that causes tumors called atypical neurofibromas. These tumors, which arise from nerves, can cause serious medical problems. The only treatment is surgery.
- Trial name
- NCT04750928
- Testing
- Abemaciclib
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- National Cancer Institute (NCI)
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