Clinical trials: CDK4/6 Inhibitor
Advanced Solid Tumor Malignancies
PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies
This study is for patients with advanced solid tumor malignancies (cancer that has spread to other parts of the body). The purpose of this study is to test the safety and effectiveness of a new combination of drugs, PD-0332991…
- Trial name
- NCT01522989
- Testing
- PD-0332991, 5-FU, Oxaliplatin
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Georgetown University
Metastatic Castration-Resistant Prostate Cancer
Abemaciclib (LY2835219) in Men With Heavily Treated Metastatic Castration-Resistant Prostate Cancer
The study will evaluate how safe and effective abemaciclib is when given to participants whose metastatic prostate cancer progresses after they had received several previous treatments.
- Trial name
- CYCLONE 1 (NCT04408924)
- Testing
- Abemaciclib
- Where
- 14 sites in United States, France and 1 more
- Volunteers
- 44 people
- Sponsor
- Eli Lilly and Company
Breast Cancer Metastatic, Breast Cancer Stage IV
Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy
After an initial screening phase to identify patients with persistent blood circulating DNA tumors, patients will be enrolled in the treatment phase that was designed as an open-label, multicentre, phase II study, to test the…
- Trial name
- SAFIR3LibHERty (NCT06680596)
- Testing
- trastuzumab derxutecan
- Where
- 40 sites in France
- Volunteers
- 80 people
- Sponsor
- UNICANCER
Recurrent Ovarian Carcinoma
Dalpiciclib Combined With Letrozole in HR+/HER2 - Gynecologic Solid Tumors
This is a prospective, single-arm, single-center registry study to investigate 6-month progression-free survival with Dalpiciclib, a CDK4/6 kinase inhibitor, plus letrozole in patients with unresectable refractory or resistant…
- Trial name
- NCT06243185
- Testing
- Dalpiciclib plus letrozole
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Fengzhi Feng
Breast Cancer
Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2…
- Trial name
- VIKTORIA-1 (NCT05501886)
- Testing
- Gedatolisib, Palbociclib, Fulvestrant
- Where
- 235 sites in United States, Argentina and 21 more
- Volunteers
- 701 people
- Sponsor
- Celcuity Inc
Breast Cancer, CDK4/6 Inhibitor
Development of a New Remote Monitoring Model for Patients With HR+HER2- Breast Cancer in Treatment With CDK4/6 Inhibitors and Hormone Therapy
This study aims to develop and prospectively validate a questionnaire to select patients with breast cancer who need to access to hospital for clinical visit during treatment with CDK4/6i, to improve patients' quality of life and…
- Trial name
- VIRTUOSA (NCT07190651)
- Testing
- Home questionnaire
- Volunteers
- 50 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Metastatic Breast Cancer
Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer
This is an open-label, multi-institution, phase Ib trial that evaluates the safety and tolerability and preliminary anti-tumor activity of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified…
- Trial name
- NCT03238196
- Testing
- Erdafitinib, Palbociclib, Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 35 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
Breast Cancer
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer.
- Trial name
- MONARCH 3 (NCT02246621)
- Testing
- Abemaciclib, Anastrozole, Letrozole
- Where
- 155 sites in United States, Australia and 20 more
- Volunteers
- 493 people
- Sponsor
- Eli Lilly and Company
Meningioma
Abemaciclib in Newly Diagnosed Meningioma Patients
This study is being done to learn about how an investigational drug called abemaciclib works in treating patients with a newly-diagnosed grade 3 meningioma.
- Trial name
- NCT05940493
- Testing
- Abemaciclib
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Nader Sanai
Metastatic Breast Cancer
Study to Evaluate the Efficacy and Safety of CDK4/6 Inhibitor SHR6390 Combined With Pyrotinib in the Treatment of HER2-positive Advanced Breast Cancer
The main purpose of this study was to observe the efficacy and safety of treatment with pyrotinib and CDK4/6 inhibitor SHR6390 for HER2-positive metastatic breast cancer.
- Trial name
- NCT03993964
- Testing
- Pyrotinib combine with SHR6390
- Volunteers
- 20 people
- Sponsor
- Sun Yat-sen University
Liposarcoma, Dedifferentiated
Open-Label Study of the CDK4/6 Inhibitor SPH4336 in Subjects With Locally Advanced or Metastatic Liposarcomas
Study SPH4336-US-01 is an open-label (no placebo), multicenter clinical trial to evaluate the safety, blood levels (pharmacokinetics) and preliminary anti-tumor effects of SPH4336, a selective enzyme blocker, in patients with…
- Trial name
- NCT05580588
- Testing
- SPH4336
- Where
- 9 sites in United States
- Volunteers
- 14 people
- Sponsor
- Shanghai Pharma Biotherapeutics USA Inc.
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
A Study of a New Drug Combination, Copanlisib and Fulvestrant, in Advanced Breast Cancer
This phase I/II trial studies the side effects and how well copanlisib works when given together with fulvestrant in treating patients with estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Brain, Prognostic Stage IV Breast Cancer AJCC v8
- Trial name
- NCT03803761
- Testing
- Copanlisib, Fulvestrant
- Where
- 7 sites in United States
- Sponsor
- National Cancer Institute (NCI)
CDK4/6 Inhibitors, Depression Anxiety Disorder
Impact of an Artificial Intelligence-Based Management Model on Psychological and Behavioral Outcomes in Breast Cancer Patients Undergoing Home CDK4/6 Inhibitor Therapy
This version uses full terminology and flows well for a research proposal or paper. Primary Objective: To compare the intervention effects of an "AI-based management model," a "customized active follow-up model," and a…
- Conditions
- CDK4/6 Inhibitors, Depression Anxiety Disorder, Breast Cancer
- Trial name
- NCT07409298
- Testing
- The "Zhiliao Doctor" AI management platform, Tailored Active Follow-up Strategy
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
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
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)
Breast Cancer Metastatic
Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer
This is a multicenter, prospective, randomized, open-label, controlled phase II study to test the addition of the CDK4/6 inhibitor ribociclib to anti-hormonal treatment as maintenance therapy in patients with disease control (at…
- Trial name
- AMICA (NCT03555877)
- Testing
- Ribociclib, Anastrozole, Letrozole
- Where
- Germany
- Volunteers
- 56 people
- Sponsor
- GBG Forschungs GmbH
Breast Cancer
Pyrotinib Maleate, CDK4/6 Inhibitor and Letrozole in Combination for Stage II-III TPBC: a Phase II Trial
The emergence of CDK4/6 inhibitors has brought hope to breast cancer patients resistant to endocrine therapy. In the mouse model, pyrotinib maleate combined with CDK4/6 inhibitor exhibits higher anti-tumor activity than any…
- Trial name
- NCT04486911
- Testing
- Pyrotinib maleate, SHR6390, letrozole
- Where
- China
- Volunteers
- 89 people
- Sponsor
- Shengjing Hospital
Breast Cancer
Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer
Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined with Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor-Resistant, HR-Positive, HER2-Negative…
- Trial name
- NCT06702618
- Testing
- TQB3616 capsule+Fulvestrant Injection
- Where
- 13 sites in China
- Volunteers
- 33 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors.
- Conditions
- Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm
- Trial name
- NCT06126276
- Testing
- Biopsy Procedure, Biospecimen Collection, Computed Tomography
- Where
- 194 sites in United States, Puerto Rico
- Volunteers
- 70 people
- Sponsor
- National Cancer Institute (NCI)
Cancer
Study of the CDK4/6 Inhibitor Abemaciclib in Solid Tumors Harboring Genetic Alterations in Genes Encoding D-Type Cyclins or Amplification of CDK4 or CDK6
This research study is studying a targeted therapy as a possible treatment for cancer abnormality in one of the following genes: CCND1, CCND2, CCND3, CDK4, or CDK6. The drug involved in this study is: -Abemaciclib
- Trial name
- NCT03310879
- Testing
- Abemaciclib
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Dana-Farber Cancer Institute