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

A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024)

Phase 1

Recruiting

Conditions: Renal Cell Carcinoma

Interventions: Drug: Belzutifan
Drug: Palbociclib

First Posted Date: 2022-07-21

Last Posted Date: 2024-12-06

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 180

Registration Number: NCT05468697

Locations: 🇮🇱
Emek Medical Center-oncology ( Site 3003), Afula, Israel
🇮🇱
Rambam Health Care Campus-Oncology ( Site 3000), Haifa, Israel
🇮🇱
Shaare Zedek Medical Center-Oncology ( Site 3002), Jerusalem, Israel

and more 9 locations

Pilot Trial for Treatment of Recurrent Glioblastoma

Early Phase 1

Recruiting

Conditions: Recurrent Glioblastoma
Glioblastoma
Recurrent Disease

Interventions: Drug: Afatinib
Drug: Dasatinib
Drug: Palbociclib
Drug: Everolimus
Drug: Olaparib

First Posted Date: 2022-06-27

Last Posted Date: 2024-06-03

Lead Sponsor: AHS Cancer Control Alberta

Target Recruit Count: 10

Registration Number: NCT05432518

Locations: 🇨🇦
Tom Baker Cancer Centre, Calgary, Alberta, Canada

Study to Evaluate Real-world Effectiveness With Palbociclib Plus Endocrine Therapy as First-line/Second-line Treatment for HR+/HER2- Advanced Breast Cancer in Japan

Active, not recruiting

Conditions: Breast Cancer

First Posted Date: 2022-06-01

Last Posted Date: 2024-07-15

Lead Sponsor: Pfizer

Target Recruit Count: 688

Registration Number: NCT05399329

Locations: 🇯🇵
Japan Community Health care Organization Kurume General Hospital, Kurume-city, Fukuoka, Japan
🇯🇵
Tohoku University Hospital, Sendai, Miyagi, Japan
🇯🇵
Osaka International Cancer Institute, Osaka-shi, Osaka, Japan

and more 17 locations

Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Drug: TTI-101
Drug: Palbociclib
Drug: Aromatase inhibitor (AI)
Drug: fulvestrant
Drug: ribociclib

First Posted Date: 2022-05-20

Last Posted Date: 2024-08-22

Lead Sponsor: Tvardi Therapeutics, Incorporated

Target Recruit Count: 6

Registration Number: NCT05384119

Locations: 🇺🇸
Holy Cross Health Fort Lauderdale - Holy Cross Hospital, Fort Lauderdale, Florida, United States
🇺🇸
Vanderbilt - Ingram Cancer Center, Nashville, Tennessee, United States
🇺🇸
Washington University School of Medicine Siteman Cancer Center, Saint Louis, Missouri, United States

and more 3 locations

Phase II Safety Single-arm Study of CDK4/6 Inhibition With Palbociclib in Hospitalized, Moderate COVID-19 Cases to Prevent Thromboinflammation

Phase 2

Withdrawn

Conditions: COVID-19

Interventions: Drug: Palbociclib

First Posted Date: 2022-05-12

Last Posted Date: 2022-11-07

Lead Sponsor: biotx.ai GmbH

Registration Number: NCT05371275

Locations: 🇩🇪
Universitätsklinikum Brandenburg an der Havel, Brandenburg an der Havel, Germany

Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer

Phase 1

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: SIM0270
Drug: Palbociclib
Drug: everolimus

First Posted Date: 2022-03-24

Last Posted Date: 2024-11-28

Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Target Recruit Count: 214

Registration Number: NCT05293964

Locations: 🇨🇳
Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients

Phase 1

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Palazestrant
Drug: Palbociclib

First Posted Date: 2022-03-04

Last Posted Date: 2024-06-06

Lead Sponsor: Olema Pharmaceuticals, Inc.

Target Recruit Count: 60

Registration Number: NCT05266105

Locations: 🇦🇺
Site 6101, Clayton, Victoria, Australia
🇦🇺
Site 6102, South Brisbane, Queensland, Australia
🇦🇺
Site 6109, Southport, Queensland, Australia

and more 5 locations

SMMART Adaptive Clinical Treatment (ACT) Trial

Early Phase 1

Withdrawn

Conditions: Advanced Breast Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8
Stage II Pancreatic Cancer AJCC v8
Stage III Ovarian Cancer AJCC v8
Advanced Prostate Carcinoma
Recurrent Adult Soft Tissue Sarcoma
Recurrent Breast Carcinoma
Stage IV Ovarian Cancer AJCC v8
Advanced Malignant Solid Neoplasm
Advanced Ovarian Carcinoma

First Posted Date: 2022-02-14

Last Posted Date: 2024-01-23

Lead Sponsor: OHSU Knight Cancer Institute

Registration Number: NCT05238831

Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies

Phase 2

Recruiting

Conditions: Head and Neck Cancer
Breast Cancer

Interventions: Drug: Palbociclib
Drug: Fulvestrant
Drug: Cetuximab
Drug: Letrozole

First Posted Date: 2022-02-07

Last Posted Date: 2024-11-12

Lead Sponsor: Pfizer

Target Recruit Count: 35

Registration Number: NCT05226871

Locations: 🇨🇳
Mackay Memorial Hospital, Taipei, Taiwan
🇲🇽
Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, Nuevo LEÓN, Mexico
🇨🇳
Hubei Cancer Hospital, Wuhan, Hubei, China

and more 13 locations

Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)

Phase 1

Active, not recruiting

Conditions: Advanced Solid Tumor

Interventions: Drug: MRTX849
Drug: Palbociclib

First Posted Date: 2022-01-05

Last Posted Date: 2024-08-05

Lead Sponsor: Mirati Therapeutics Inc.

Target Recruit Count: 11

Registration Number: NCT05178888

Locations: 🇺🇸
Local Institution - 803, Nashville, Tennessee, United States
🇺🇸
NEXT Oncology - NEXT San Antonio, San Antonio, Texas, United States
🇺🇸
Local Institution - 804, Orlando, Florida, United States

and more 1 locations

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