Clinical trials: Palbociclib
Metastatic Breast Cancer, Breast Cancer Stage I
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07002177
- Testing
- FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet
- Where
- China
- Volunteers
- 196 people
- Sponsor
- Forward Pharmaceuticals Co., Ltd.
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.
Solid Tumors, NSCLC
A Study of Telaglenastat (CB-839) in Combination With Palbociclib in Patients With Solid Tumors
This is a Phase 1b/2 study to determine the recommended phase 2 dose (RP2D), safety and tolerability, pharmacokinetics (PK) and clinical activity of the glutaminase inhibitor telaglenestat (CB-839) with the CDK4/6 Inhibitor…
- Conditions
- Solid Tumors, NSCLC, CRC, KRAS Gene Mutation
- Trial name
- NCT03965845
- Testing
- Telaglenestat (CB-839), Palbociclib Oral Capsule or Tablet [Ibrance]
- Where
- 10 sites in United States
- Volunteers
- 53 people
- Sponsor
- Calithera Biosciences, Inc
Breast Cancer, Solid Tumor, Adult
A Study to Investigate the Safety, Tolerability, of APG-2575 as a Single Agent or in Combination for Breast Cancer
This is a multi-center, open-label, phase Ib/II study of APG-2575 as a single agent in patients with advanced solid tumors or in combination with anti-cancer agents such as CDK 4/6 inhibitor palbociclib in patients with ER+/HER2…
- Trial name
- NCT04946864
- Testing
- APG-2575, Palbociclib
- Where
- 7 sites in United States, China
- Volunteers
- 65 people
- Sponsor
- Ascentage Pharma Group Inc.
HR+ HER2- Breast Cancer
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants…
- Trial name
- NCT07558733
- Testing
- Serabelisib, Sapanisertib, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Faeth Therapeutics
Neoplasms, Breast Neoplasms
A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer
This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1 portion is a single-country, non-randomized, open label, clinical trial which will evaluate the safety, tolerability, preliminary…
- Trial name
- NCT01684215
- Testing
- PD-0332991, letrozole
- Where
- 16 sites in Japan
- Volunteers
- 61 people
- Sponsor
- Pfizer
Breast Cancer
Study to Evaluate Patient Reported Outcome (PRO) and Physical Activity in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy
The study is a prospective, multicenter, observational study to evaluate PRO and physical activity using smartphone-based application and wearable device in Japanese patients with HR+/HER2- advanced breast cancer (ABC).
- Trial name
- JBCRG-26 (NCT04736576)
- Testing
- Wearable device
- Where
- 20 sites in Japan
- Volunteers
- 99 people
- 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
Breast Cancer
Treatment Landscape and Real-World Dosing Patterns With CDK4/6 Inhibitors for Breast Cancer in Portugal
Assess and characterize the real-world cyclin-dependent kinase 4/6 inhibitor (CDKI) use in advanced/metastatic breast cancer (a/mBC), evaluate treatment persistence, and quantify CDKI dose adjustments in Portugal.
- Trial name
- PORTRAIT (NCT07223476)
- Where
- United States
- Volunteers
- 1,926 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
A Single-Radiolabeled Dose Mass Balance Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] Palbociclib (PD-0332991) In Healthy Male Volunteers
This will be an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of PD-0332991 in approximately 6 healthy male subjects receiving a single oral 125 mg dose of PD-0332991 containing approximately…
- Trial name
- NCT01756768
- Testing
- [14C]-PD-0332991
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pfizer
Breast Cancer
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal…
- Trial name
- NCT05384119
- Testing
- TTI-101, Palbociclib, Aromatase inhibitor (AI)
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Tvardi Therapeutics, Incorporated
Breast Neoplasm
Post Marketing Surveillance Study to Observe Safety and Efficacy of IBRANCE®
This non-interventional study is designated as a Post Marketing Surveillance Study and is a commitment to Ministry of Food and Drug Safety (MFDS).
- Trial name
- NCT03445637
- Where
- South Korea
- Volunteers
- 552 people
- Sponsor
- Pfizer
Healthy
A Study In Healthy Volunteers To Estimate The Effect Of The Active Ingredient Particle Size And Percentage Of The Excipients Used To Formulate The Capsules In The Dissolution Rate Of The Formulations In The Gastrointestinal Tract
The particle size of the active ingredient may impact dissolution rate in the gastro intestinal tract and hence the amount of drug available for absorption.
- Trial name
- NCT01844323
- Testing
- Palbociclib Formulation Reference, Palbociclib Formulation Test
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study To Investigate The Drug-Drug Interaction Potential Of Rifampin OnThe Investigational Agent Palbociclib (PD-0332991)
This study will compare the plasma pharmacokinetics of a single 125mg oral dose of palbociclib in the presence and absence of rifampin-mediated enzyme induction in a fixed-sequence two-period study.
- Trial name
- NCT01953731
- Testing
- Palbociclib, Rifampin
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Pfizer
HER2+/HR+ Breast Cancer
Phase 2a Study of ZW25 in Combination With Palbociclib Plus Fulvestrant
This is a multicenter, Phase 2a, open-label, 2-part study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) in combination with palbociclib plus fulvestrant.
- Trial name
- NCT04224272
- Testing
- ZW25 (Zanidatamab), Palbociclib, Fulvestrant
- Where
- 13 sites in United States, Canada and 1 more
- Volunteers
- 51 people
- Sponsor
- Jazz Pharmaceuticals
Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as…
- Conditions
- Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT06570031
- Testing
- ONO-4578, letrozole, Palbociclib
- Where
- 13 sites in Japan
- Volunteers
- 46 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Breast Neoplasms
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast…
- Trial name
- NCT01740427
- Testing
- PD-0332991, Letrozole
- Where
- 305 sites in United States, Australia and 16 more
- Volunteers
- 666 people
- Sponsor
- Pfizer
Lymphoma, Mantle-Cell
An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.
This is a pilot study evaluating tumor activity using Positron Emission Tomography, which is also known as a "PET scan". This study will assess the safety of using PD-0332991 in patients with mantle cell lymphoma.
- Trial name
- NCT00420056
- Testing
- PD-0332991
- Where
- 6 sites in United States
- Volunteers
- 17 people
- Sponsor
- Pfizer
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor…
- Trial name
- NCT06065748
- Testing
- Giredestrant, Fulvestrant, Abemaciclib
- Where
- 311 sites in United States, Argentina and 35 more
- Volunteers
- 1,050 people
- Sponsor
- Hoffmann-La Roche
Bioequivalence
Bioequivalence Study of Palbociclib 125 mg Capsules of Iclos vs. Ibrance (Palbociclib) Capsules 125 mg
An open label, balanced, randomized, two treatments, two sequences, two periods, cross over, single dose, bioequivalence study of Palbociclib 125 mg Capsules of Iclos Uruguay S.A and IBRANCE® (Palbociclib) 125 mg Capsules of…
- Trial name
- NCT06331715
- Testing
- Palbociclib 125mg
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Megalabs