Palbociclib

Generic Name: Palbociclib

Brand Names: Ibrance

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₉N_₇O_₂

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: -

Clinical Trials

A Study of Palbociclib in Combination With Bazedoxifene in Hormone Receptor Positive Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer Stage IV
Metastatic Invasive Breast Cancer
Unresectable Locally Advanced Invasive Breast Cancer

Interventions: Drug: Palbociclib
Drug: Bazedoxifene

First Posted Date: 2015-05-19

Last Posted Date: 2022-10-24

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 36

Registration Number: NCT02448771

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women

Phase 2

Completed

Conditions: Neoadjuvant Operable Breast Cancer

Interventions: Drug: Fluorouracile
Drug: Letrozole
Drug: Epirubicin
Drug: Palbociclib
Drug: Cyclophosphamide

First Posted Date: 2015-03-27

Last Posted Date: 2022-03-15

Lead Sponsor: UNICANCER

Target Recruit Count: 125

Registration Number: NCT02400567

Locations: 🇫🇷
Gustave Roussy, Villejuif, France
🇫🇷
Institut Curie, Paris, France

A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer

Phase 2

Completed

Conditions: Metastatic Breast Cancer
Hormone Receptor Positive

Interventions: Drug: Palbociclib
Drug: Tamoxifen
Drug: Fulvestrant

First Posted Date: 2015-03-10

Last Posted Date: 2022-03-16

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 70

Registration Number: NCT02384239

Locations: 🇺🇸
Georgetown University, Washington, District of Columbia, United States
🇺🇸
Baylor College of Medicine, Houston, Texas, United States
🇺🇸
University of Michigan, Ann Arbor, Michigan, United States

and more 6 locations

Study For Patients With NSCLC EGFR Mutations (Del 19 or L858R +/- T790M)

Phase 1

Terminated

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: PF-06747775
Drug: Palbociclib
Drug: Avelumab

First Posted Date: 2015-01-29

Last Posted Date: 2021-06-10

Lead Sponsor: Pfizer

Target Recruit Count: 65

Registration Number: NCT02349633

Locations: 🇺🇸
UPMC Cancer Pavilion, Pittsburgh, Pennsylvania, United States
🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
🇦🇺
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia

and more 12 locations

Phase II Trial of Palbociclib in Patients With Metastatic Urothelial Cancer After Failure of First-Line Chemotherapy

Phase 2

Terminated

Conditions: Metastatic Urothelial Carcinoma (UC)

Interventions: Drug: Palbociclib

First Posted Date: 2015-01-08

Last Posted Date: 2018-11-16

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 12

Registration Number: NCT02334527

Locations: 🇺🇸
University of Michigan, Ann Arbor, Michigan, United States
🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
🇺🇸
North Carolina Cancer Hospital (UNC), Chapel Hill, North Carolina, United States

Study of Palbociclib in MLL-rearranged Acute Leukemias

Phase 1

Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia

Interventions: Drug: Palbociclib

First Posted Date: 2014-12-08

Last Posted Date: 2019-04-16

Lead Sponsor: University of Ulm

Target Recruit Count: 50

Registration Number: NCT02310243

Locations: 🇩🇪
Universitätsklinikum Schleswig-Holstein Campus Kiel, Kiel, Germany
🇩🇪
Medizinische Hochschule Hannover, Hannover, Germany
🇩🇪
Universitätsklinikum Giessen, Giessen, Germany

and more 21 locations

A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]

Phase 3

Active, not recruiting

Conditions: Breast Neoplasms

Interventions: Drug: Placebo
Drug: Palbociclib
Drug: Letrozole

First Posted Date: 2014-11-21

Last Posted Date: 2024-10-21

Lead Sponsor: Pfizer

Target Recruit Count: 340

Registration Number: NCT02297438

Locations: 🇨🇳
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
🇨🇳
The Tumor Hospital of Yunnan Province, Kunming, Yunnan, China
🇨🇳
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China

and more 51 locations

A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer
Breast Carcinoma
Breast Tumors

Interventions: Drug: Letrozole
Drug: palbociclib

First Posted Date: 2014-11-20

Last Posted Date: 2022-01-13

Lead Sponsor: NSABP Foundation Inc

Target Recruit Count: 307

Registration Number: NCT02296801

Locations: 🇺🇸
Metro-Minnesota CCOP, Saint Louis Park, Minnesota, United States
🇺🇸
Hope Women's Cancer Centers, Asheville, North Carolina, United States
🇺🇸
University of Pittsburgh, Pittsburgh, Pennsylvania, United States

and more 48 locations

Ibrutinib and Palbociclib in Treating Patients With Previously Treated Mantle Cell Lymphoma

Phase 1

Active, not recruiting

Conditions: Recurrent Mantle Cell Lymphoma

Interventions: Drug: Ibrutinib
Other: Laboratory Biomarker Analysis
Drug: Palbociclib
Other: Pharmacological Study

First Posted Date: 2014-06-10

Last Posted Date: 2024-08-02

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 28

Registration Number: NCT02159755

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸
NYP/Weill Cornell Medical Center, New York, New York, United States
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States

and more 1 locations

Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer

Completed

Conditions: Recurrent Squamous Cell Lung Carcinoma
Stage IV Squamous Cell Lung Carcinoma AJCC v7

Interventions: Biological: Durvalumab
Drug: Docetaxel
Drug: FGFR Inhibitor AZD4547
Drug: Erlotinib Hydrochloride
Biological: Ipilimumab
Other: Laboratory Biomarker Analysis
Drug: Taselisib
Drug: Palbociclib
Biological: Nivolumab
Biological: Rilotumumab
Other: Pharmacological Study
Drug: Talazoparib
Biological: Tremelimumab

First Posted Date: 2014-06-03

Last Posted Date: 2023-06-01

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 1864

Registration Number: NCT02154490

Locations: 🇺🇸
Riverside Methodist Hospital, Columbus, Ohio, United States
🇺🇸
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
🇺🇸
Los Angeles County-USC Medical Center, Los Angeles, California, United States

and more 997 locations

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