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
Bladder Cancer
Clinical Trail of Neoadjuvant of Tislelizumab Combined With Palbociclib in Patients With Platinum-refractory Bladder Urothelial Carcinoma
In order to explore the safety and antitumor efficacy of different doses of CDK4/6 inhibitor Palbociclib in combination with the Tislelizumab in platinum-refractory cT2-4aN0M0 bladder urothelial carcinoma, a phase Ib/II study was…
- Trial name
- NCT06364956
- Testing
- Tislelizumab combined with two predefined dose groups of palbociclib, RP2D dose Of Tislelizumab combined with palbociclib was selected for phase II clinical trial.
- Where
- 8 sites in China
- Volunteers
- 36 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ER+ Breast Cancer, HER2-negative Breast Cancer
A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer
Detection of molecular relapse with circulating tumour DNA analysis can identify which patients with ER positive breast cancer are relapsing on adjuvant endocrine therapy.
- Trial name
- TRAK-ER (NCT04985266)
- Testing
- Palbociclib 125Mg Tab, Fulvestrant injection, Tamoxifen
- Where
- 49 sites in France, United Kingdom
- Volunteers
- 1,100 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Breast Neoplasm Female
Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer
Given the uncertain benefit in efficacy of adding CDK 4/6 to first rather than second line endocrine treatment, the aim of this project is to evaluate whether the sequence of an aromatase inhibitor plus CDK 4/6 in first line…
- Trial name
- NCT03425838
- Testing
- CDK 4/6 inhibitor, Non-Steroidal Aromatase Inhibitor, Fulvestrant
- Where
- 72 sites in Netherlands
- Volunteers
- 1,050 people
- Sponsor
- Borstkanker Onderzoek Groep
Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Real-life Treatment Patterns With Cyclin-dependent Kinase Inhibitors in Advanced Breast Cancer in Portugal - REVEAL Study
This was a non-interventional (observational), retrospective, cohort study of women with hormone receptor (HR)-positive and human epidermal growth factor receptor-type 2 (HER2)-negative advanced breast cancer who started…
- Trial name
- NCT06463626
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Novartis
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)
Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial
This phase Ib trial is to find out the best dose, possible benefits and/or side effects of talazoparib when given in combination with palbociclib, axitinib, or crizotinib in treating patients with solid tumors that has spread to…
- Conditions
- Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
- Trial name
- NCT04693468
- Testing
- Axitinib, Crizotinib, Palbociclib Isethionate
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- M.D. Anderson Cancer Center
Non-small Cell Lung Cancer
Cyclin Dependent Kinase (CDK)4/6 Inhibitor, PD0332991 in Advanced Non-small Cell Lung Cancer NSCLC.
The purpose of this study is to determine the efficacy and the toxicities of the study drug PD0332991 in the treatment of patients with Stage IV non-small cell lung cancer with wildtype retinoblastoma protein (RB) and inactivated…
- Trial name
- NCT01291017
- Testing
- PD0332991
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- University of Florida
Healthy
A Study To Investigate The Drug-Drug Interaction Potential Of Rifampin OnThe Investigational Agent Palbociclib (PD-0332991)
This study will compare the plasma pharmacokinetics of a single 125mg oral dose of palbociclib in the presence and absence of rifampin-mediated enzyme induction in a fixed-sequence two-period study.
- Trial name
- NCT01953731
- Testing
- Palbociclib, Rifampin
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Pfizer
Well-differentiated/Dedifferentiated Liposarcoma
Palbociclib and INCMGA00012 in People With Advanced Liposarcoma
The researchers are doing this study to find out whether combining the study drugs palbociclib and INCMGA00012 is an effective and safe treatment for advanced liposarcoma. "Funding Source - FDA OOPD"
- Trial name
- NCT04438824
- Testing
- INCMGA00012, Palbociclib
- Where
- 7 sites in United States
- Volunteers
- 42 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Solid Tumors
Study of INCB123667 in Subjects With Advanced Solid Tumors
This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy and in combination with…
- Trial name
- NCT05238922
- Testing
- INCB0123667, Palbociclib, Bevacizumab
- Where
- 41 sites in United States, France and 6 more
- Volunteers
- 291 people
- Sponsor
- Incyte Corporation
Breast Cancer, Hormonreceptor Positive
A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery
The PENELOPEB study is designed to demonstrate that, in the background of standard anti-hormonal therapy, palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women…
- Conditions
- Breast Cancer, Hormonreceptor Positive, Her2-normal, Postneoadjuvant Treatment With CDK 4/6 Inhibitor
- Trial name
- PENELOPE-B (NCT01864746)
- Testing
- Palbociclib PD-0332991
- Where
- 11 sites in United States, Australia and 9 more
- Volunteers
- 1,250 people
- Sponsor
- GBG Forschungs GmbH
Ovarian Cancer
Palbociclib Plus Letrozole Treatment After Progression to Second Line Chemotherapy for Women With ER/PR-positive Ovarian Cancer
The primary objective of this study is to evaluate 12 weeks progression-free survival (PFS) rate of Palbociclib plus Letrozole in ER/PR positive endometrioid or high-grade serous ovarian cancer who have disease progression on…
- Trial name
- NCT03936270
- Testing
- Palbociclib 125mg, Letrozole 2.5mg
- Where
- 5 sites in Brazil
- Volunteers
- 43 people
- Sponsor
- Latin American Cooperative Oncology Group
Breast Cancer, Cancer
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer
- Trial name
- CheckMate 7A8 (NCT04075604)
- Testing
- Nivolumab, Anastrozole, Palbociclib
- Where
- 36 sites in United States, Australia and 6 more
- Volunteers
- 23 people
- Sponsor
- Bristol-Myers Squibb
Thymic Cancer
A Phase II Study of Palbociclib for Recurrent or Refractory Advanced Thymic Epithelial Tumor
This is a phase II single center, open-label, single arm study of palbociclib treatment in patients with recurrent or metastatic advanced TETs after failure of one or more cytotoxic chemotherapy regimens.
- Trial name
- NCT03219554
- Testing
- Palbociclib
- Where
- South Korea
- Volunteers
- 33 people
- Sponsor
- Samsung Medical Center
Hormone Receptor Positive Breast Cancer, Metastatic Breast Cancer
CDK4/6-inhibitor or Chemotherapy, in Combination with ENDOcrine Therapy, for Advanced Breast Cancer / KENDO
Prospective, open label, multicenter, group sequential response adaptive randomized phase 2 study, comparing two treatments for locally advanced or metastatic luminal breast cancer: Arm A: concomitant cyclin-dependent Kinase 4/6…
- Conditions
- Hormone Receptor Positive Breast Cancer, Metastatic Breast Cancer, Hormone Receptor Negative Breast Cancer
- Trial name
- KENDO (NCT03227328)
- Testing
- concomitant cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor plus endocrine therapy, chemotherapy plus endocrine therapy (administered either concomitantly or sequentially)
- Where
- 20 sites in Italy
- Volunteers
- 52 people
- Sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Multiple Myeloma
Palbociclib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma
Our hypothesis is that treating relapsed or refractory multiple myeloma with PD 0332991 (Palbociclib) in combination with lenalidomide will result will be both effectively inducing myeloma plasma cell death as well maintaining a…
- Trial name
- PD + RD (NCT02030483)
- Testing
- Palbociclib, Dexamethasone, Lenalidomide
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Weill Medical College of Cornell University
Breast Cancer, Estrogen Receptor Positive Tumor
To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)
This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in…
- Conditions
- Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer
- Trial name
- TOUCH (NCT03644186)
- Testing
- Paclitaxel, Trastuzumab, Pertuzumab
- Where
- 54 sites in Belgium, France and 2 more
- Volunteers
- 147 people
- Sponsor
- ETOP IBCSG Partners Foundation
HR Positive/HER-2 Negative Breast Cancer
Adding Capivasertib to Standard Treatment in HR Positive, HER2 Negative Metastatic Breast Cancer Based on ctDNA Testing
The purpose of this research is to see if adding the investigational targeted drug capivasertib to standard endocrine therapy (hormone-blocking treatment) combined with a medicine that slows cancer cell growth can improve…
- Trial name
- MONITOR (NCT07802626)
- Testing
- NSAI + CDK4/6i, NSAI + CDK4/6i + Capivasertib, Fulvestrant + CDK4/6i + Capivasertib
- Volunteers
- 1,084 people
- Sponsor
- SWOG Cancer Research Network
Breast Cancer
Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer
Pfizer's innovative drug palbociclib (trade name: Ibrance®) got China National Drug Administration (CNDA) approval on July 31, 2018.
- Trial name
- NCT04047758
- Testing
- Palbociclib + Letrozole, Letrozole
- Where
- 3 sites in China
- Volunteers
- 420 people
- Sponsor
- Shengjing Hospital