Clinical trials: Palbociclib
Breast Neoplasms
Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2 ) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region
retrospective non-interventional study (NIS) that aims to describe the demographics, clinical characteristics, clinical outcomes, and treatment patterns, among patients receiving palbociclib for the treatment of HR+/HER2…
- Trial name
- NCT04916509
- Testing
- Palbociclib plus an aromatase inhibitor, Palbociclib plus fulvestrant
- Where
- 7 sites in Qatar, Saudi Arabia and 1 more
- Volunteers
- 258 people
- Sponsor
- Pfizer
Patients With Advanced Solid Tumors
A Study of LAE118 as Monotherapy and in Combination With Antitumor Agents in Advanced Solid Tumors
Study Title: A Phase I, Open-Label, Dose-Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of LAE118 as Monotherapy and in Combination With Other Antitumor Agents in…
- Trial name
- NCT07787520
- Testing
- LAE118, Fulvestrant, Palbociclib
- Where
- 6 sites in China
- Volunteers
- 150 people
- Sponsor
- Laekna Limited
Healthy
A Pilot Study To Investigate The Effect Of Concurrent Antacid Administration On The Bioavailability Of Six Experimental Formulations Of Palbociclib
This study will investigate whether concurrent administration of rabeprazole, an antacid known as a proton pump inhibitor, alters the absorption of the drug palbociclib when given as one of six experimental formulations.
- Trial name
- NCT02311946
- Testing
- Palbociclib Alone, Palbociclib + Rabeprazole
- Where
- 3 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pfizer
Breast Cancer
Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole
This is a retrospective, multicenter, observational study in Japan. The primary objective is to evaluate overall survival (OS) in Japanese patients with HR+/HER2- advanced breast cancer who have been treated with palbociclib plus…
- Trial name
- NCT04735367
- Testing
- palbociclib plus letrozole
- Where
- 13 sites in Japan
- Volunteers
- 42 people
- Sponsor
- Pfizer
Advanced and Metastatic Breast Cancer
Study of AZD2014 and Palbociclib in Patients With Estrogen Receptor Positive (ER+) Metastatic Breast Cancer
This dose finding/extension study was designed originally to consist of three parts: Part A was intended to identify the MTD of the AZD2014/ palbociclib combination on a background of fulvestrant (referred to as the triplet) in…
- Trial name
- PASTOR (NCT02599714)
- Testing
- AZD2014, Palbociclib, Fulvestrant
- Where
- 7 sites in United States, United Kingdom
- Volunteers
- 54 people
- Sponsor
- AstraZeneca
Breast Cancer, Malignant Neoplasm of Breast
A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer
Palbociclib, the first oral CDK4/6 inhibitor, is an approved medicine indicated for the treatment of a kind of advanced/metastatic breast cancer (MBC), called hormone receptors positive (HR+)/ Human epidermal growth factor…
- Trial name
- NCT06495164
- Testing
- Palbociclib, Aromatase inhibitor, Ribociclib
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Pfizer
Advanced Breast Cancer
A Phase Ib/II Study of QLC1401 Combined With CDK4/6 or mTOR Inhibitors in ER+/HER2- Advanced Breast Cancer
This study is an open-label, multicenter, Phase Ib/II clinical trial designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of QLC1401 tablets in combination with CDK4/6 inhibitors or mTOR…
- Trial name
- NCT07173556
- Testing
- QLC1401
- Volunteers
- 96 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Carcinoma, Ductal, Breast, Breast Cancer Female
G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer
This is a study to investigate the potential clinical benefit of G1T48 as an oral selective estrogen receptor degrader (SERD) alone and in combination with palbociclib, a cyclin dependent kinase 4/6 (CDK 4/6) inhibitor, in…
- Conditions
- Carcinoma, Ductal, Breast, Breast Cancer Female, Breast Neoplasm, Breast Cancer
- Trial name
- NCT03455270
- Testing
- G1T48, Palbociclib
- Where
- 15 sites in United States, Belgium and 5 more
- Volunteers
- 107 people
- Sponsor
- G1 Therapeutics, Inc.
Breast Cancer, Breast Carcinoma
A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer
The purpose of this clinical study is to describe the patient population, breast cancer treatment, and breast cancer treatment results of adult female patients who have received palbociclib combination treatments for advanced or…
- Conditions
- Breast Cancer, Breast Carcinoma, Breast Neoplasms, Breast Tumors
- Trial name
- NCT05584644
- Testing
- Palbociclib plus hormonal treatment - first line treatment, Palbociclib plus hormonal treatment - second line treatment
- Where
- 6 sites in India
- Volunteers
- 150 people
- Sponsor
- Pfizer
Healthy
A Study To Investigate Palbociclib (PD-0332991) Pharmacokinetics In Healthy Subjects Of Japanese Descent Relative To Healthy Non-Asian Subjects, And To Determine If Changes In Palbociclib Dose Result In Proportional Changes In Palbociclib Plasma Exposure In Japanese Subjects
This study will investigate the dose-proportionality of palbociclib pharmacokinetics in healthy subjects of Japanese descent. Approximately fourteen healthy Japanese subjects will receive four single doses of palbociclib…
- Trial name
- NCT02059330
- Testing
- Palbociclib 75mg, Palbociclib 125mg, Palbociclib 100mg
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Pfizer
Breast Cancer, Hormone Receptor Positive Tumor
Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant
The purpose of this study is to evaluate the efficacy and quality of life in women with advanced breast cancer (locally advance inoperable or metastatic adenocarcinoma of the breast), HR+ / HER2-, who are treated with an…
- Conditions
- Breast Cancer, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Trial name
- INGE-B (NCT02894398)
- Testing
- Palbociclib, Letrozole, Anastrozole
- Where
- 70 sites in Germany
- Volunteers
- 388 people
- Sponsor
- iOMEDICO AG
Healthy Volunteer
Proton Pump Inhibitor (PPI, Rabeprazole) Effect On Tablet Formulation Of Palbociclib
to evaluate the effect of the PPI (rabeprazole) on the PK of a potential commercial tablet formulation of palbociclib
- Trial name
- NCT03220191
- Testing
- Palbociclib, Rabeprazole
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Metastatic Breast Cancer
Analysis of the Real-world Prescription Pattern of Palbociclib Combination Therapy With Aromatase Inhibitor as a First Line Therapy in Metastatic Breast Cancer Patients Using the National Health Insurance Claims Data in South Korea
The objective of this study is to evaluate the real-world prescription patterns of Palbociclib in breast cancer (BC) patients who were treated with Palbociclib in combination with AI as a 1st line of therapy using the national…
- Trial name
- NCT05132101
- Testing
- Patients who received Palbociclib as first line therapy in MBC setting
- Where
- South Korea
- Volunteers
- 2,758 people
- Sponsor
- Pfizer
Breast Cancer, Diabetes Type II
A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes
This study will evaluate the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes.
- Trial name
- NCT07748208
- Testing
- Inavolisib, Fulvestrant, Palbociclib
- Where
- 10 sites in United States, Puerto Rico
- Volunteers
- 40 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients Diagnosed With HR+/HER2 Advanced/Metastatic Breast Cancer on Palbociclib + Aromatase Inhibitor (AI) Combination Therapy
The study is designed to describe patient characteristics, treatment patterns, and clinical effectiveness outcomes in patients diagnosed with HR+/HER2- A/MBC who received palbociclib combination therapy with AI as first-line…
- Trial name
- NCT04394247
- Where
- United States
- Volunteers
- 242 people
- Sponsor
- Pfizer
Healthy
Relative Bioavailability For Palbociclib Formulations
This study is to assess the relative bioavailability of palbociclib hard gelatin capsule formulation (API 41 micrometer and dissolution Level 1) and palbociclib hard gelatin capsule formulation (API 16 micrometer and dissolution…
- Trial name
- NCT02083640
- Testing
- Palbociclib Formulation Reference, Palbociclib Formulation Test
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions
A relative bioavailability study of commercial palbociclib free base hard capsules to the isethionate salt palbociclib capsules ( used in Phase 1 and 2 studies) under different fasting conditions.
- Trial name
- NCT02041273
- Testing
- palbociclib isethionate (phase 1 and 2 studies), palbociclib commercial free base capsule
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer
Breast Neoplasm
Impact of eHealth-support on Quality of Life in Metastatic Breast Cancer Patients Treated With Palbociclib and Endocrine Therapy
In this study the investigators assess the impact of the eHealth-supported therapy management system CANKADO on Quality of Life in patients with HR+, HER2-locally advanced or metastatic breast cancer treated with the cyclin…
- Trial name
- PRECYCLE (NCT03220178)
- Testing
- Palbociclib, Fulvestrant, Anastrozole
- Where
- Germany
- Volunteers
- 532 people
- Sponsor
- Palleos Healthcare GmbH
Healthy
Relative Bioavailability Study
This is a BA study comparing the bioavailability of two new capsule formulations and one solution formulation to the isethionate capsule used in phase 1 and 2 trials in healthy volunteers.
- Trial name
- NCT01602887
- Testing
- PD-0332991
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Advanced Breast Cancer, Metastatic Breast Cancer
Palbociclib in Real World Practice
This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer.
- Trial name
- NCT03280303
- Testing
- non-interventional
- Where
- 305 sites in United States, Canada
- Volunteers
- 1,285 people
- Sponsor
- Pfizer