Clinical trials: Palbociclib
Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia
Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients With Recurrent or Refractory Leukemia
This phase I trial studies the side effects and best dose of palbociclib when given alone and in combination with sorafenib, decitabine, or dexamethasone in treating patients with leukemia that has come back (recurrent) or that…
- Conditions
- Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia, Refractory Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia
- Trial name
- NCT03132454
- Testing
- Decitabine, Dexamethasone, Palbociclib
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- M.D. Anderson Cancer Center
Advanced Malignant Solid Neoplasm, Recurrent Childhood Ependymoma
Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial)
This phase II Pediatric MATCH trial studies how well palbociclib works in treating patients with Rb positive solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating alterations (mutations) in cell cycle genes…
- Conditions
- Advanced Malignant Solid Neoplasm, Recurrent Childhood Ependymoma, Recurrent Ewing Sarcoma, Recurrent Glioma
- Trial name
- NCT03526250
- Testing
- Laboratory Biomarker Analysis, Palbociclib, Pharmacological Study
- Where
- 117 sites in United States, Puerto Rico
- Volunteers
- 23 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Real-world Treatment Patterns of Endocrine Based Therapy Among Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor-2-negative (HR+/HER2-) Advanced Breast Cancer: An Analysis of Administrative Claims Data in Japan
This is a retrospective observational study focusing on patients diagnosed with advanced breast cancer(ABC) in Japan using de-identified claim data from Medical Data Vision (MDV) database.
- Trial name
- NCT05153187
- Where
- Japan
- Volunteers
- 1,170 people
- Sponsor
- Pfizer
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
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
Ewing Sarcoma, Ewing's Sarcoma Recurrent
Palbociclib + Ganitumab In Ewing Sarcoma
This research study is designed to study the combination of two drugs, palbociclib and ganitumab, as a potential treatment for Ewing sarcoma. The names of the study drugs involved in this study are: Palbociclib Ganitumab
- Trial name
- NCT04129151
- Testing
- Palbociclib, Ganitumab
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Dana-Farber Cancer Institute
Metastatic Breast Cancer
Palbociclib Induced Neutropenia; Risk Factors and Treatment Outcome in Metastatic Breast Cancer Patients
Aim of the study to assess the neutropenia induced by Palbociclib in patient receiving Palbociclib in combination with hormonal treatment as first-line therapy in metastatic hormone receptor- positive HER2 negative breast cancer.
- Trial name
- NCT06076772
- Testing
- Palbociclib
- Where
- Saudi Arabia
- Volunteers
- 54 people
- Sponsor
- Assiut University
Breast Cancer
A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer.
- Trial name
- NCT06307457
- Testing
- Palbociclib in combination with AI
- Where
- Denmark
- Volunteers
- 604 people
- Sponsor
- Pfizer
Breast Cancer Stage IV
The Resistance and Immune Response to Palbociclib in Breast Cancer
The investigators propose to conduct a biomarker and molecular profiling study in longitudinally paired tumor biopsies and serum from patients with Hormone Receptor positive (HR+) metastatic Breast Cancer (BC) treated with…
- Trial name
- NCT03401359
- Testing
- tissue biopsy, blood sample
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Samsung Medical Center
Medulloblastoma, Childhood
Novel Molecular Targets and Innovative Therapeutic Perspective in Medulloblastoma
Medulloblastoma (MB), a rare yet critical pediatric brain tumor, is divided into 4 molecular subgroups (WNT, SHH, Group 3, Group 4), each with distinct genetic profiles.
- Trial name
- NCT06959979
- Testing
- CDK4/6 Inhibitor (Palbociclib, Ribociclib, Abemaciclib)
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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
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
Breast Neoplasms
A Study to Understand About the Study Medicine Palbociclib in Breast Cancer Patients After it is Out in the Japanese Market
The purpose of the study is to: compare the chances of getting interstitial lung disease (ILD) in new users of palbociclib plus fulvestrant to new users of fulvestrant alone (using data from before palbociclib was out in the…
- Trial name
- NCT07096024
- Testing
- palbociclib plus fulvestrant, fulvestrant
- Where
- United States
- Volunteers
- 95,637 people
- Sponsor
- Pfizer
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
Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)
This phase II Pediatric MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have…
- Conditions
- Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Histiocytic Sarcoma
- Trial name
- NCT03155620
- Testing
- Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration and Biopsy
- Where
- 172 sites in United States, Australia and 2 more
- Volunteers
- 1,377 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)
A randomized, Phase II trial of circulating tumor DNA-guided second line Adjuvant therapy for high Residual risk, Estrogen Receptor positive, HER-2 negative breast cancer (DARE)
- Trial name
- DARE (NCT04567420)
- Testing
- Palbociclib, Fulvestrant, Adjuvant Therapy
- Where
- 19 sites in United States
- Volunteers
- 70 people
- Sponsor
- Criterium, Inc.
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
Cancer
Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study
This study is looking at outcomes in people with advanced cancers who have exhausted standard treatment options and are accessing off indication or unregistered drugs or combinations of drugs through compassionate access from the…
- Trial name
- TAILOR (NCT04801966)
- Testing
- Trametinib, Cobimetinib, Binimetinib
- Where
- Australia
- Volunteers
- 3 people
- Sponsor
- Peter MacCallum Cancer Centre, Australia
Sarcoma
Palbociclib and Pembrolizumab in Sarcoma
This is a single-arm open-label window of opportunity clinical study assessing the impact of pre-treatment with palbociclib in patients with soft tissue sarcomas for which PD-1 inhibitors are approved (includes undifferentiated…
- Trial name
- NCT06113809
- Testing
- Palbociclib, Pembrolizumab
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- John Rieth
Acute Lymphoblastic Leukemia, Pediatric, Relapsed Acute Lymphoblastic Leukemia
Palbociclib in Combo w/Chemotherapy in Peds Relapsed/Refractory Acute Lymphoblastic Leukemia
With this research study has following goals To confirm the highest tolerable dose of palbociclib in combination with chemotherapy is safe and well-tolerated.
- Conditions
- Acute Lymphoblastic Leukemia, Pediatric, Relapsed Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia
- Trial name
- NCT04996160
- Testing
- Palbociclib, Dexamethasone, Bortezomib
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Tanja Andrea Gruber