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.

Palbociclib was developed by Pfizer Inc after the discovery that identified the cyclin-dependent kinases as key regulators of cell growth. It was originally FDA approved on March 2015 for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer and its indications were updated in April 2019 to include male patients based on findings from postmarketing reports and electronic health records demonstrating safety and clinical efficacy.

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 progression with prior endocrine therapy.

In the official labeling, the use of palbociclib should be accompanied with either an aromatase inhibition, no restricted to letrozole, as initial endocrine-based therapy in postmenopausal women or in man.

The breast cancer starts as a group of cancer cells that grow into and destroy the nearby breast tissue. This growth can spread into other parts of the body which is called metastasis. According to the location of the cancer cells, it can be categorized in ductal carcinoma and lobular carcinoma. However, other types of breast cancer include inflammatory breast cancer, Paget disease of the breast, triple negative breast cancer non-Hodgkin lymphoma and soft tissue sarcoma. In males, breast cancer is usually treated as the cases of postmenopausal women and almost all the cases are ductal carcinoma.

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

Phase II Palbociclib +Ibrutinib in Mantle Cell Lymphoma

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-03-27
Last Posted Date
2024-05-06
Lead Sponsor
Alliance Foundation Trials, LLC.
Target Recruit Count
39
Registration Number
NCT03478514
Locations
🇺🇸

St. Joseph Mercy Hospital Cancer Care Center, Ypsilanti, Michigan, United States

🇺🇸

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

🇺🇸

Medical University of South Carolina - Hollings Cancer Center, Charleston, South Carolina, United States

and more 6 locations

Palbociclib and Dexamethasone in Treating Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia

First Posted Date
2018-03-21
Last Posted Date
2024-03-13
Lead Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Target Recruit Count
7
Registration Number
NCT03472573
Locations
🇺🇸

Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States

A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer

Phase 1
Completed
Conditions
Interventions
First Posted Date
2018-03-20
Last Posted Date
2024-01-08
Lead Sponsor
InventisBio Co., Ltd
Target Recruit Count
200
Registration Number
NCT03471663
Locations
🇨🇳

Local Institution, Shenyang, Liaoning, China

G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer

First Posted Date
2018-03-06
Last Posted Date
2022-12-15
Lead Sponsor
G1 Therapeutics, Inc.
Target Recruit Count
107
Registration Number
NCT03455270
Locations
🇺🇦

Spizhenko Clinic, Kiev, Ukraine

🇧🇪

Institut Jules Bordet, Brussels, Belgium

🇧🇪

UZ Leuven, Leuven, Belgium

and more 12 locations

Efficacy of Palbociclib in Advanced Acral Melanoma With Cell Cycle Gene Aberrations

Phase 2
Conditions
Interventions
First Posted Date
2018-03-06
Last Posted Date
2018-03-06
Lead Sponsor
Peking University Cancer Hospital & Institute
Target Recruit Count
60
Registration Number
NCT03454919

Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors

First Posted Date
2018-03-05
Last Posted Date
2024-08-02
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center
Target Recruit Count
45
Registration Number
NCT03454035
Locations
🇺🇸

Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

Palbociclib and Cetuximab in Metastatic Colorectal Cancer

First Posted Date
2018-02-26
Last Posted Date
2024-08-07
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center
Target Recruit Count
24
Registration Number
NCT03446157
Locations
🇺🇸

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States

PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2018-02-06
Last Posted Date
2024-03-22
Lead Sponsor
National Cancer Center, Japan
Target Recruit Count
180
Registration Number
NCT03423199
Locations
🇰🇷

Seoul National University Hospital, Seoul, Korea, Republic of

🇨🇳

Sun Yat-Sen Cancer Center, Taipei, Taiwan

🇯🇵

Chiba Cancer Center, Chiba, Japan

and more 20 locations

Survival Prolongation by Rationale Innovative Genomics

First Posted Date
2017-12-29
Last Posted Date
2023-12-18
Lead Sponsor
Worldwide Innovative Network Association
Target Recruit Count
15
Registration Number
NCT03386929
Locations
🇺🇸

Avera Cancer Center, Sioux Falls, South Dakota, United States

🇱🇺

Centre Hospitalier Luxembourg, Luxembourg, Luxembourg

🇮🇱

Chaim Sheba Medical Center, Ramat Gan, Israel

and more 2 locations
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