Palbociclib

Generic Name
Palbociclib
Brand Names
Ibrance
Drug Type
Small Molecule
Chemical Formula
C24H29N7O2
CAS Number
571190-30-2
Unique Ingredient Identifier
G9ZF61LE7G
Background

Palbociclib is a piperazine pyridopyrimidine that acts in the cell cycle machinery. It is a second generation cyclin-dependent kinase inhibitor selected from a group of pyridopyrimidine compounds due to its favorable physical and pharmaceutical properties.
...

Indication

Palbociclib is indicated in combination with letrozole as initial endocrine-based therapy for the treatment of human epidermal growth factor receptor type 2 (HER2)-negative and hormone receptor(HR)-positive tumors in adult patients with advanced/metastatic breast cancer. It is as well approved in combination with fulvestrant in patients with disease progress...

Associated Conditions
Advanced Breast Cancer, Metastatic Breast Cancer, Refractory, advanced Breast cancer, Refractory, metastatic Breast cancer
Associated Therapies
-

Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate

First Posted Date
2014-05-20
Last Posted Date
2018-12-21
Lead Sponsor
Pfizer
Registration Number
NCT02142868
Locations
🇺🇸

Presence Saint Joseph Hospital, Chicago, Illinois, United States

🇺🇸

Presence Infusion Care - Skokie, Skokie, Illinois, United States

🇺🇸

SKCCC at Johns Hopkins, The Harry and Jeannette Weinberg Building, Baltimore, Maryland, United States

and more 42 locations

Study Of Palbociclib (PD-0332991) In Renal Impairment

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-03-13
Last Posted Date
2018-04-30
Lead Sponsor
Pfizer
Target Recruit Count
31
Registration Number
NCT02085538
Locations
🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

🇺🇸

Avail Clinical Research, LLC, DeLand, Florida, United States

🇺🇸

Prism Research, Saint Paul, Minnesota, United States

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Anti-Cancer Activity of Trametinib in Combination With Palbociclib in Subjects With Solid Tumors

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-02-17
Last Posted Date
2018-06-01
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
28
Registration Number
NCT02065063
Locations
🇺🇸

GSK Investigational Site, Houston, Texas, United States

Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-01-20
Last Posted Date
2024-02-22
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
162
Registration Number
NCT02040857
Locations
🇺🇸

MGH/North Shore Cancer Center, Danvers, Massachusetts, United States

🇺🇸

University of California, San Francisco, San Francisco, California, United States

🇺🇸

South Shore Hospital, Weymouth, Massachusetts, United States

and more 7 locations

Palbociclib in Combination With Lenalidomide and Dexamethasone for Multiple Myeloma

First Posted Date
2014-01-08
Last Posted Date
2018-08-22
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
9
Registration Number
NCT02030483
Locations
🇺🇸

Weill Cornell Medical College, New York, New York, United States

Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors

First Posted Date
2014-01-07
Last Posted Date
2021-01-20
Lead Sponsor
Spanish Breast Cancer Research Group
Target Recruit Count
693
Registration Number
NCT02028507
Locations
🇮🇱

Sheba Medical Center, Tel Hashomer, Israel

🇦🇹

Universitätsklinik für Innere Medizin III, Salzburg, Austria

🇦🇹

Landes-Krankenhaus Steyr, Steyr, Austria

and more 34 locations

PALBOCICLIB + PD-0325901 for NSCLC & Solid Tumors

First Posted Date
2013-12-30
Last Posted Date
2024-03-19
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
60
Registration Number
NCT02022982
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

A Study To Investigate The Drug-Drug Interaction Potential Of Rifampin OnThe Investigational Agent Palbociclib (PD-0332991)

Phase 1
Completed
Conditions
Interventions
First Posted Date
2013-10-01
Last Posted Date
2014-01-20
Lead Sponsor
Pfizer
Target Recruit Count
15
Registration Number
NCT01953731
Locations
🇺🇸

Pfizer Investigational Site, New Haven, Connecticut, United States

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

First Posted Date
2013-09-13
Last Posted Date
2024-04-04
Lead Sponsor
Pfizer
Target Recruit Count
521
Registration Number
NCT01942135
Locations
🇺🇸

Holy Cross Hospital/Michael and Dianne Bienes Comprehensive Cancer Center, Fort Lauderdale, Florida, United States

🇺🇸

Sylvester Comprehensive Cancer Center Deerfield Beach, Deerfield Beach, Florida, United States

🇺🇸

Memorial Cancer Institute at Memorial Hospital West, Pembroke Pines, Florida, United States

and more 214 locations
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