PD-0332991

DRUG9 trials

Sponsors

Pfizer, Abramson Cancer Center at Penn Medicine, Sidney Kimmel Cancer Center at Thomas Jefferson University, Georgetown University

Conditions

Adenocarcinoma of the ColonAdenocarcinoma of the RectumAdult Central Nervous System Germ Cell TumorAdult Solid TumorAdult TeratomaAdvanced Hepatocellular CarcinomaAdvanced Solid Tumor MalignanciesBenign Teratoma

Phase 1

A Study Of Oral Palbociclib (PD-0332991), A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer

CompletedNCT00141297

PfizerLymphoma, Non-Hodgkin, Neoplasms

Start: 2004-09-30End: 2014-12-31Updated: 2016-01-05

An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.

CompletedNCT00420056

PfizerLymphoma, Mantle-Cell

Start: 2007-05-31End: 2012-03-31Updated: 2015-10-28

PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies

Georgetown UniversityAdvanced Solid Tumor Malignancies

Start: 2011-12-31End: 2020-12-31Updated: 2020-03-04

Relative Bioavailability Study

CompletedNCT01602887

Start: 2012-05-31End: 2012-11-30Updated: 2012-11-12

A Drug-Drug Interaction Study To Investigate The Potential For Multiple Doses Of Palbociclib (PD-0332991) To Alter The Pharmacokinetics Of Oral Midazolam In Adult Healthy Women of Non-Childbearing Potential.

CompletedNCT01756781

Start: 2013-05-31End: 2013-07-31Updated: 2015-10-08

Phase 2

Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer

CompletedNCT01037790

Abramson Cancer Center at Penn MedicineAdenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Adult Central Nervous System Germ Cell Tumor +36

Start: 2009-10-31End: 2019-10-31Updated: 2021-03-11

A Clinical Research Study to Determine Whether PD 0332991 May Be Effective in Treating Patients With Liver Cancer

CompletedNCT01356628

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityAdvanced Hepatocellular Carcinoma, HCC, Liver Cancer

Start: 2011-05-25End: 2023-12-16Updated: 2025-07-28

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

CompletedNCT01684215

PfizerBreast Neoplasms, Neoplasms

Start: 2012-10-19End: 2018-10-25Updated: 2020-11-23

Phase 3

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

CompletedNCT01740427

PfizerBreast Neoplasms

Start: 2013-02-22End: 2023-11-09Updated: 2024-11-14

Related Papers

Correction: Overcoming chemoresistance in esophageal cancer with synergistic strategies

Frontiers in Immunology2026-07-03

Effect of cross-platform gene-expression, computational methods on breast cancer subtyping in PALOMA-2 and PALLET studies

npj Breast Cancer2024-06-291 citations

Clinical efficacy of CDK4/6 inhibitor plus endocrine therapy in HR-positive/HER2-0 and HER2-low-positive metastatic breast cancer: a secondary analysis of PALOMA-2 and PALOMA-3 trials.

2024-06-1015 citations

Matching-adjusted indirect comparison of PFS and OS comparing ribociclib plus letrozole <i>versus</i> palbociclib plus letrozole as first-line treatment of HR+/HER2- advanced breast cancer.

2023-12-1410 citations

Overall survival in Japanese patients with ER+/HER2− advanced breast cancer treated with first-line palbociclib plus letrozole

Breast Cancer2023-10-264 citations

Abstract 1069: A novel PAThway based RNA and DNA Integration with Tumor Organoid Testing (PATRIOTTM) platform predicts therapeutic options in cohorts with MET overexpression and CDKN2A downregulation in patients with colon and pancreatic cancers

Cancer Research2023-04-04

On-treatment derived neutrophil-to-lymphocyte ratio and survival with palbociclib and endocrine treatment: analysis of a multicenter retrospective cohort and the PALOMA-2/3 study with immune correlates.

2023-01-1219 citations

Cost-effectiveness of ribociclib versus palbociclib in combination with an aromatase inhibitor as first-line treatment of postmenopausal women with HR+/HER2- advanced breast cancer: analysis based on final OS results of MONALEESA-2 and PALOMA-2.

2023-01-015 citations

Effect of palbociclib plus endocrine therapy on time to chemotherapy across subgroups of patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer: Post hoc analyses from PALOMA-2 and PALOMA-3.

2022-11-159 citations

Comparative biomarker analysis of PALOMA-2/3 trials for palbociclib.

2022-08-1623 citations

Overall survival (OS) with first-line palbociclib plus letrozole (PAL+LET) versus placebo plus letrozole (PBO+LET) in women with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer (ER+/HER2− ABC): Analyses from PALOMA-2.

Journal of Clinical Oncology2022-06-08167 citations

Abstract PD2-07: Impact of using cross-platform gene expression profiling technologies and computational methods for intrinsic breast cancer subtyping in PALOMA-2 and PALLET

Cancer Research2022-02-151 citations

Abstract P1-18-13: Efficacy and safety of palbociclib plus endocrine therapy in Black and Hispanic patients with hormone receptor positive/human epidermal growth factor receptor 2-negative advanced breast cancer (HR+/HER2- ABC) participating in the PALOMA trials

Cancer Research2022-02-151 citations

Efficacy and safety of palbociclib in patients with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with preexisting conditions: A post hoc analysis of PALOMA-2.

2021-07-2826 citations

On-treatment derived neutrophil-to-lymphocyte ratio and response to palbociclib and letrozole: Analysis of a multicenter retrospective cohort and the PALOMA-2 study.

Journal of Clinical Oncology2021-05-20

Evaluation of the Association of Polymorphisms With Palbociclib-Induced Neutropenia: Pharmacogenetic Analysis of PALOMA-2/-3

The Oncologist2021-05-0625 citations

Abstract PS10-14: Efficacy and safety of palbociclib (PAL) in patients (pts) with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) with preexisting conditions: A post hoc analysis of PALOMA-2

Cancer Research2021-02-15

Impact of Dose Reduction on Efficacy: Implications of Exposure-Response Analysis of Palbociclib.

2021-01-0129 citations

Treatment effect of palbociclib plus endocrine therapy by prognostic and intrinsic subtype and biomarker analysis in patients with bone-only disease: a joint analysis of PALOMA-2 and PALOMA-3 clinical trials.

2020-08-1124 citations

Early treatment-related neutropenia predicts response to palbociclib

British Journal of Cancer2020-07-0838 citations

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