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.
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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

PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer

Phase 1

Recruiting

Conditions: Triple Negative Breast Cancer
Locally Advanced Breast Cancer
Recurrent Breast Cancer
Metastatic Breast Cancer
ER+ Breast Cancer
HER2-positive Breast Cancer

Interventions: Drug: Palbociclib
Drug: Avelumab

First Posted Date: 2020-04-24

Last Posted Date: 2024-10-07

Lead Sponsor: Royal Marsden NHS Foundation Trust

Target Recruit Count: 45

Registration Number: NCT04360941

Locations: 🇬🇧
Addenbrooke's Hospital Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom
🇬🇧
The Christie NHS Foundation Trust, Manchester, Greater Manchester, United Kingdom
🇬🇧
Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom

and more 4 locations

Palbociclib Plus Fulvestrant in Women With Hormone Receptor Positive and Human Epidermal Growth Factor Receptor Type 2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination With Hormonal Therapy

Phase 2

Conditions: Metastatic Breast Cancer
Locally Advanced Breast Cancer

Interventions: Drug: Palbociclib

First Posted Date: 2020-03-23

Last Posted Date: 2020-03-23

Lead Sponsor: Consorzio Oncotech

Target Recruit Count: 168

Registration Number: NCT04318223

Locations: 🇮🇹
Istituto Nazionale Tumori Regina Elena (IRE, Roma, Italy
🇮🇹
Università degli Studi di Napoli "Federico II", Napoli, Italy
🇮🇹
Nuovo ospedale di Prato - S. Stefano, Prato, Firenze, Italy

and more 16 locations

Predicted Biomarkers of CDK4/6 Inhibitors (Palbociclib) in ER-positive Metastasis Breast Cancer

Conditions: Breast Cancer

Interventions: Drug: Palbociclib

First Posted Date: 2020-02-28

Last Posted Date: 2020-02-28

Lead Sponsor: Chinese Academy of Medical Sciences

Target Recruit Count: 100

Registration Number: NCT04289974

Locations: 🇨🇳
Cancer Hospital, ChineseAMS, Beijing, Beijing, China

Aromatase Inhibitor Therapy With or Without Fulvestrant for the Treatment of HR Positive Metastatic Breast Cancer With an ERS1 Activating Mutation, the INTERACT Study

Phase 2

Completed

Conditions: Metastatic Breast Carcinoma
Prognostic Stage IV Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8

Interventions: Drug: Abemaciclib
Drug: Anastrozole
Drug: Fulvestrant
Drug: Letrozole
Drug: Palbociclib
Drug: Ribociclib

First Posted Date: 2020-02-05

Last Posted Date: 2024-04-16

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 4

Registration Number: NCT04256941

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

High Risk ER+HER2- T1-2N0-1 Early Breast Cancer With Palbociclib Plus Endocrine Therapy(HIPEx)

Phase 2

Recruiting

Conditions: Breast Cancer

Interventions: Drug: Palbociclib

First Posted Date: 2020-01-30

Last Posted Date: 2020-04-20

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 578

Registration Number: NCT04247633

Locations: 🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer

Phase 2

Active, not recruiting

Conditions: HER2+/HR+ Breast Cancer

Interventions: Drug: ZW25 (Zanidatamab)
Drug: Palbociclib
Drug: Fulvestrant

First Posted Date: 2020-01-13

Last Posted Date: 2024-08-14

Lead Sponsor: Jazz Pharmaceuticals

Target Recruit Count: 51

Registration Number: NCT04224272

Locations: 🇺🇸
Seattle Cancer Care Alliance, Seattle, Washington, United States
🇺🇸
UCLA Hematology/Oncology Parkside, Santa Monica, California, United States
🇺🇸
Sarah Cannon Research Institute, Nashville, Tennessee, United States

and more 10 locations

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer

Phase 2

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Inavolisib
Drug: Placebo
Drug: Palbociclib
Drug: Fulvestrant

First Posted Date: 2019-12-09

Last Posted Date: 2024-10-09

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 325

Registration Number: NCT04191499

Locations: 🇪🇸
Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
🇪🇸
Hospital Universitario de Canarias;servicio de Oncologia, La Laguna, Tenerife, Spain
🇪🇸
Hospital del Mar; Servicio de Oncologia, Barcelona, Spain

and more 155 locations

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Phase 1

Recruiting

Conditions: Advanced Solid Tumors
Kirsten Rat Sarcoma (KRAS) pG12C Mutation

Interventions: Drug: Sotorasib
Drug: RMC-4630
Drug: Afatinib
Drug: MVASI® (bevacizumab-awwb)
Drug: Atezolizumab
Drug: TNO155
Drug: BI 1701963
Drug: AMG 404
Drug: Trametinib
Drug: Pembrolizumab
Drug: Palbociclib
Drug: Everolimus
Drug: IV Chemotherapy (Regimen 1)
Drug: Carboplatin, pemetrexed, docetaxel, paclitaxel
Drug: Panitumumab
Drug: IV Chemotherapy (Regimen 2)

First Posted Date: 2019-12-04

Last Posted Date: 2024-11-28

Lead Sponsor: Amgen

Target Recruit Count: 1200

Registration Number: NCT04185883

Locations: 🇺🇸
Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion), Detroit, Michigan, United States
🇺🇸
Arizona Oncology Associates Professional Corporation, Tucson, Arizona, United States
🇺🇸
City of Hope National Medical Center, Duarte, California, United States

and more 87 locations

Palbociclib Plus Letrozole in Hormone Receptor Positive Residual Disease After Neoadjuvant Chemotherapy

Early Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: Palbociclib
Drug: Letrozole

First Posted Date: 2019-10-17

Last Posted Date: 2022-10-25

Lead Sponsor: SOLTI Breast Cancer Research Group

Target Recruit Count: 22

Registration Number: NCT04130152

Locations: 🇪🇸
Hospital General de Catalunya, Barcelona, Spain
🇪🇸
ICO Hospitalet, Barcelona, Spain
🇪🇸
Hospital 12 de octubre, Madrid, Spain

and more 5 locations

Palbociclib + Ganitumab In Ewing Sarcoma

Phase 2

Terminated

Conditions: Ewing's Sarcoma Recurrent
Ewing Sarcoma

Interventions: Drug: Palbociclib
Drug: Ganitumab

First Posted Date: 2019-10-16

Last Posted Date: 2024-08-01

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 10

Registration Number: NCT04129151

Locations: 🇺🇸
Boston Children's Hospital, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

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