Clinical trials: Palbociclib, completed
Neoplasms, Breast Neoplasms
A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer
This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1 portion is a single-country, non-randomized, open label, clinical trial which will evaluate the safety, tolerability, preliminary…
- Trial name
- NCT01684215
- Testing
- PD-0332991, letrozole
- Where
- 16 sites in Japan
- Volunteers
- 61 people
- Sponsor
- Pfizer
Prostate Cancer
A Phase II Study of Androgen Deprivation Therapy With or Without Palbociclib in RB-Positive Metastatic Prostate Cancer
This study will look at the effect of adding the drug Palbociclib to CAD (Combined Androgen Deprivation) therapy in patients with RB (Retinoblastoma Protein) positive hormone sensitive prostate cancer.
- Trial name
- NCT02059213
- Testing
- Ibrance, Bicalutamide, Zoladex
- Where
- 8 sites in United States
- Volunteers
- 72 people
- Sponsor
- University of Michigan Rogel Cancer Center
Breast Cancer
Treatment Patterns and Clinical Outcomes Among Patients With HR+/HER2- mBC Receiving Palbociclib Combination Therapy in the US Community Oncology Setting.
By leveraging a community-based, cancer-specific electronic healthcare record for this study, we aim to understand treatment patterns and clinical outcomes among patients with HR+/HER2- mBC who received care within the context of…
- Trial name
- NCT04460911
- Where
- United States
- Volunteers
- 317 people
- Sponsor
- Pfizer
Metastatic Breast Cancer, Hormone Receptor Positive
A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer
This phase II trial studies the side effects of palbociclib when given together with fulvestrant or tamoxifen citrate in treating patients with hormone receptor positive breast cancer that has spread from where it started to…
- Trial name
- NCT02384239
- Testing
- Palbociclib, Tamoxifen, Fulvestrant
- Where
- 9 sites in United States
- Volunteers
- 70 people
- Sponsor
- University of California, San Francisco
Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8
Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer
This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or…
- Conditions
- Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8
- Trial name
- NCT03981614
- Testing
- Binimetinib, Palbociclib, Trifluridine and Tipiracil Hydrochloride
- Where
- 7 sites in United States
- Volunteers
- 102 people
- Sponsor
- Academic and Community Cancer Research United
Breast Cancer
Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2 Advanced/Metastatic Breast Cancer on Palbociclib + Aromatase Inhibitor (AI) Combination Therapy
The study is designed to describe patient characteristics, treatment patterns, and clinical effectiveness outcomes in patients diagnosed with HR+/HER2- A/MBC who received palbociclib combination therapy with AI as first-line…
- Trial name
- NCT04394247
- Where
- United States
- Volunteers
- 242 people
- Sponsor
- Pfizer
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
Acute Myeloid Leukemia, AML
Phase I/II Trial of CPX-351 + Palbociclib in Patients With Acute Myeloid Leukemia
The purpose of this study is to evaluate the safety and tolerability of Palbociclib in combination with investigational (experimental) drug, CPX-351 and evaluate the efficacy of Palbociclib in combination with chemotherapy as…
- Trial name
- NCT03844997
- Testing
- Palcociclib, CPX-351
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Sudipto Mukherjee, MD, PhD, MPH
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
Hormone Receptor Positive HER-2 Negative Breast Cancer
Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer
This study aims to evaluate the hematological safety of palbociclib with letrozole and fulvestrant in African American women with hormone receptor positive HER2 negative advanced breast cancer.
- Trial name
- PALINA (NCT02692755)
- Testing
- Palbociclib + Letrozole or Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 35 people
- Sponsor
- Georgetown University
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 Stage IV, Unresectable Locally Advanced Invasive Breast Cancer
A Study of Palbociclib in Combination With Bazedoxifene in Hormone Receptor Positive Breast Cancer
This research study is studying a drug called Palbociclib in combination with Bazedoxifene (a type of endocrine therapy, which prevents breast cancer cell growth by blocking estrogen stimulation) as a possible treatment for this…
- Conditions
- Breast Cancer Stage IV, Unresectable Locally Advanced Invasive Breast Cancer, Metastatic Invasive Breast Cancer
- Trial name
- NCT02448771
- Testing
- Palbociclib, Bazedoxifene
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- Dana-Farber Cancer Institute
Metastatic Breast Cancer
Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer
This international, multicenter, prospective single arm Phase II biomarker discovery clinical trial with the primary objective of assessing the association of PFS with gene mutations, gene copy number aberrations and gene…
- Trial name
- PYTHIA (NCT02536742)
- Testing
- Palbociclib, Fulvestrant
- Where
- 19 sites in Belgium, Italy and 1 more
- Volunteers
- 124 people
- Sponsor
- ETOP IBCSG Partners Foundation
HR+/HER2- Locally Advanced, Metastatic Breast Cancer
UK Ibrance Patient Program (IPP) Study
What are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in United Kingdom patients…
- Trial name
- ROIS (NCT03921866)
- Testing
- Palbociclib
- Where
- 8 sites in United Kingdom
- Volunteers
- 191 people
- Sponsor
- Pfizer
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
Advanced Gastrointestinal Stromal Tumors
Efficacy and Safety of PD-0332991 in Advanced Gastrointestinal Stromal Tumors Refractory to Imatinib and Sunitinib
The treatment of advanced GIST patients is based on imatinib followed with sunitinib in case of resistance/intolerance. However, the median progression-free survival (PFS) on sunitinib is frequently short, and after failure with…
- Trial name
- CYCLIGIST (NCT01907607)
- Testing
- PD 0332991
- Where
- 9 sites in France
- Volunteers
- 29 people
- Sponsor
- Institut Bergonié
Recurrent Squamous Cell Lung Carcinoma, Stage IV Squamous Cell Lung Carcinoma AJCC v7
Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer
This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid…
- Trial name
- NCT02154490
- Testing
- Docetaxel, Durvalumab, Erlotinib Hydrochloride
- Where
- 1,004 sites in United States, Canada
- Volunteers
- 1,864 people
- Sponsor
- SWOG Cancer Research Network
Breast Cancer
A Study of ZN-c5 in Subjects With Breast Cancer
This is a Phase 1/2, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-c5 administered orally in subjects with advanced estrogen…
- Trial name
- NCT03560531
- Testing
- ZN-c5, Palbociclib
- Where
- 38 sites in United States, Belarus and 7 more
- Volunteers
- 181 people
- Sponsor
- Zeno Alpha Inc.
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
Breast Cancer
Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer
The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer
- Trial name
- NCT00721409
- Testing
- PD 0332991, letrozole
- Where
- 104 sites in United States, Canada and 10 more
- Volunteers
- 177 people
- Sponsor
- Pfizer