Clinical trials: Palbociclib
Breast Cancer
A Phase I/II Trial to Evaluate Oral HP568 Tablets in Patients with ER+/HER2 Advanced Breast Cancer
This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and preliminary efficacy of HP568 alone and in combination with palbociclib in patients with ER+/HER2- locally advanced or…
- Trial name
- NCT06757335
- Testing
- HP568, HP568 in combination with palbociclib
- Volunteers
- 204 people
- Sponsor
- Hinova Pharmaceuticals Inc.
Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages.
- Trial name
- Morpheus-panBC (NCT03424005)
- Testing
- Capecitabine, Atezolizumab, Ipatasertib
- Where
- 55 sites in United States, Australia and 7 more
- Volunteers
- 1,132 people
- Sponsor
- Hoffmann-La Roche
Advanced Breast Cancer
A Study of Sirolimus (Albumin-Bound) in Combination With Palbociclib and Fulvestrant for the Treatment of Advanced Breast Cancer
This study adopts multicenter/randomized trial design. It plans to enroll patients with HR- positive, HER2- negative advanced breast cancer who are resistant to (neo)adjuvant endocrine therapy.
- Trial name
- NCT06941142
- Testing
- Sirolimus (albumin - bound), Palbociclib tablet, Fulvestrant injection
- Volunteers
- 382 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
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
Advanced Solid Tumor, HR+/HER2- Breast Cancer
Study of AVZO-021 in Patients With Advanced Solid Tumors
This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer, CCNE1 Amplification
- Trial name
- NCT05867251
- Testing
- AVZO-021, Palbociclib, Fulvestrant
- Where
- 13 sites in United States, Australia
- Volunteers
- 430 people
- Sponsor
- Avenzo Therapeutics, Inc.
Locally Advanced Breast Cancer, Metastatic Breast Cancer
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated…
- Trial name
- reaINAVO (NCT07347600)
- Testing
- Inavolisib, Palbociclib, Fulvestrant
- Where
- 32 sites in China
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche
Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Real-life Treatment Patterns With Cyclin-dependent Kinase Inhibitors in Advanced Breast Cancer in Portugal - REVEAL Study
This was a non-interventional (observational), retrospective, cohort study of women with hormone receptor (HR)-positive and human epidermal growth factor receptor-type 2 (HER2)-negative advanced breast cancer who started…
- Trial name
- NCT06463626
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Novartis
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
Solid Tumors
Study of INCB123667 in Subjects With Advanced Solid Tumors
This is an open-label, dose-escalation and dose-expansion study to determine the safety, tolerability, PK, pharmacodynamics, and preliminary efficacy of INCB123667 when administered as monotherapy and in combination with…
- Trial name
- NCT05238922
- Testing
- INCB0123667, Palbociclib, Bevacizumab
- Where
- 41 sites in United States, France and 6 more
- Volunteers
- 291 people
- Sponsor
- Incyte Corporation
Breast Cancer, Cancer
A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer
A randomized multi-arm study evaluating the safety and efficacy of palbociclib and anastrozole with or without nivolumab in participants with ER+/HER2- breast cancer
- Trial name
- CheckMate 7A8 (NCT04075604)
- Testing
- Nivolumab, Anastrozole, Palbociclib
- Where
- 36 sites in United States, Australia and 6 more
- Volunteers
- 23 people
- Sponsor
- Bristol-Myers Squibb
Breast Cancer
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
The purpose of this study is to determine the safety and efficacy of PF-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people with breast cancer: HR-positive…
- Trial name
- FourLight-3 (NCT06760637)
- Testing
- PF-07220060, letrozole, abemaciclib
- Where
- 460 sites in United States, Argentina and 28 more
- Volunteers
- 1,035 people
- Sponsor
- Pfizer
Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with…
- Trial name
- NCT04546009
- Testing
- Giredestrant, Letrozole, Palbociclib
- Where
- 255 sites in United States, Argentina and 28 more
- Volunteers
- 992 people
- Sponsor
- Hoffmann-La Roche
Advanced Solid Tumors
SNV4818 in Participants With Advanced Solid Tumors
This study is testing a new medicine, SNV4818, for people with advanced cancers. The researchers want to find out if SNV4818 is safe, well-tolerated, and effective in treating solid tumors.
- Trial name
- NCT06736704
- Testing
- SNV4818, Fulvestrant, Palbociclib
- Where
- 12 sites in United States, Australia and 1 more
- Volunteers
- 320 people
- Sponsor
- Pikavation Therapeutics, Inc.
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.
Breast Cancer
Real-world Treatment Patterns of Endocrine Based Therapy Among Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor-2-negative (HR+/HER2-) Advanced Breast Cancer: An Analysis of Administrative Claims Data in Japan
This is a retrospective observational study focusing on patients diagnosed with advanced breast cancer(ABC) in Japan using de-identified claim data from Medical Data Vision (MDV) database.
- Trial name
- NCT05153187
- Where
- Japan
- Volunteers
- 1,170 people
- Sponsor
- Pfizer
Advanced Breast Cancer
Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer
As part of the global clinical development program for Palbociclib, studies are planned in cancer patients in China. An assessment of Palbociclib pharmacokinetics in Chinese patients, as required by the Chinese Health…
- Trial name
- NCT02499146
- Testing
- Palbociclib, Letrozole
- Where
- 7 sites in China
- Volunteers
- 26 people
- Sponsor
- Pfizer
PIK3CA Mutation, Solid Tumor, Adult
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor…
- Conditions
- PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05759949
- Testing
- RLY-5836, Fulvestrant, Palbociclib
- Where
- 7 sites in United States
- Volunteers
- 41 people
- Sponsor
- Relay Therapeutics, Inc.
Healthy
A Study Comparing the Plasma Drug Exposure of an Oral Dose of Palbociclib (PD-0332991) to an Intravenous Dose of Palbociclib (PD-0332991)
The purpose of this study is to determine approximately what percentage of an orally administered dose of PD-0332991 is absorbed from the gastrointestinal tract into the systemic circulation.
- Trial name
- NCT01802476
- Testing
- Oral Drug Formulation of PD-0332991, Intravenous Formulation of PD-0332991
- Where
- United Kingdom
- Volunteers
- 14 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
ER+, HER2-, Metastatic Breast Cancer
AZD9833 China PK Study
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Chinese patients with ER Positive, HER2 Negative, Metastatic Breast Cancer
- Trial name
- AZD9833 (NCT04818632)
- Testing
- AZD9833, AZD9833 with palbociclib, AZD9833 with everolimus
- Where
- 4 sites in China
- Volunteers
- 28 people
- Sponsor
- AstraZeneca