Clinical trials: Palbociclib, open to volunteers
Bladder Cancer
Clinical Trail of Neoadjuvant of Tislelizumab Combined With Palbociclib in Patients With Platinum-refractory Bladder Urothelial Carcinoma
In order to explore the safety and antitumor efficacy of different doses of CDK4/6 inhibitor Palbociclib in combination with the Tislelizumab in platinum-refractory cT2-4aN0M0 bladder urothelial carcinoma, a phase Ib/II study was…
- Trial name
- NCT06364956
- Testing
- Tislelizumab combined with two predefined dose groups of palbociclib, RP2D dose Of Tislelizumab combined with palbociclib was selected for phase II clinical trial.
- Where
- 8 sites in China
- Volunteers
- 36 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. The study is designed with the flexibility to open new treatment arms as new treatments become available, close…
- Trial name
- NCT04802759
- Testing
- Giredestrant, Abemaciclib, Ipatasertib
- Where
- 32 sites in United States, Australia and 3 more
- Volunteers
- 316 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Real-world Studies of CDK4/6 Inhibitors
A single-center, real-world study evaluated the clinical outcomes and safety of CDK4/6 inhibitors combined with endocrine therapy in HR+/HER2- advanced breast cancer, and conducted a summary analysis of the clinical treatment…
- Trial name
- NCT07407439
- Where
- China
- Volunteers
- 245 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Solid Tumors Refractory to Standard Therapy
Interventional Study to Evaluate the Combination of Palbociclib + Sunitinib as a Treatment for Advanced Solid Tumors
The goal of this clinical trial is to learn if a combination of Palbociclib and Sunitinib is safe and effective in various solid tumors.
- Trial name
- COPS-01 (NCT06940349)
- Testing
- Palbociclib, Sunitinib
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Rabin Medical Center
Breast Cancer, Stage IV Breast Cancer
Surgery vs. No Surgery for Primary Tumor in De Novo Stage IV Breast Cancer With Solitary Bone Metastases
This is a national multicenter, prospective, randomized controlled trial. The study aims to compare the 5-year overall survival (OS) between patients receiving primary tumor surgery followed by systemic therapy (surgery group)…
- Conditions
- Breast Cancer, Stage IV Breast Cancer, Bone Metastases
- Trial name
- POSITIVE-Bone (NCT07687225)
- Testing
- Primary Tumor Resection, Standard systemic therapy
- Volunteers
- 216 people
- Sponsor
- West China Hospital
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.
Advanced Breast Cancer
Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer
This is a prospective, randomised, controlled, multicentre study to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal growth factor receptor…
- Trial name
- ITHRAN (NCT07180160)
- Testing
- QL1706, CDK4/6 inhibitor, Fulvestrant
- Where
- China
- Volunteers
- 123 people
- Sponsor
- Wenjin Yin
Salivary Gland Carcinoma, Precision Therapy
Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing
Patients with salivary gland carcinoma were divided into groups according to HER2, NTRK, AR, TROP-2, etc. Patients in different groups were given precision targeted therapy or chemotherapy to evaluate the efficacy (ORR rate) and…
- Trial name
- NCT06145308
- Testing
- Cohort 1 (HER2-positive, RC48-ADC), Cohort 2 (NTRK-fusion or NTRK-mutant), Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone)
- Where
- 2 sites in China
- Volunteers
- 39 people
- Sponsor
- Peking Union Medical College
Breast Neoplasms, Solid Tumors
A Phase 1/2a Study of K-1728 in Advanced Solid Tumors
This first-in-human, open-label, multicenter study evaluates K-1728 administered as monotherapy and in combination in participants with advanced or metastatic solid tumors.
- Conditions
- Breast Neoplasms, Solid Tumors, PIK3CA Gene Mutation
- Trial name
- PIKYMA-01 (NCT07861932)
- Testing
- K-1728, Fulvestrant, Palbociclib
- Volunteers
- 110 people
- Sponsor
- KymaThera, Inc.
Breast Cancer
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2…
- Trial name
- NCT06757634
- Testing
- Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole
- Where
- 239 sites in United States, Argentina and 23 more
- Volunteers
- 1,180 people
- Sponsor
- Celcuity Inc
Nasopharyngeal Carcinoma
Umbrella Biomarker-Guided Therapy in NPC
This is a phase 2, open-label, umbrella study, with the purpose to evaluate the therapeutic efficacy and safety of chemoradiotherapy in combination with immunotherapy and/or targeted treatment in high-risk locoregionally advanced…
- Trial name
- NCT04605562
- Testing
- GP+DDP, Palbociclib, Intensity-modulated radiotherapy
- Where
- China
- Volunteers
- 206 people
- Sponsor
- Sun Yat-sen University
Metastatic Breast Cancer, ER Positive Breast Cancer
To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer
This is a multi-center biomarkers study aiming to prospectively collect biological samples from patients with ER+ and HER2-negative metastatic breast cancer, who are candidate to first-line treatment with an aromatase inhibitor…
- Conditions
- Metastatic Breast Cancer, ER Positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- TIRESIAS (NCT04660435)
- Testing
- Thymidine kinase activity
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Fondazione Sandro Pitigliani
Premenopausal HR+/HER2- Metastatic Breast Cancer
PALbociclib Endocrine Therapy Followed by Talazo Vs. Talazoz-Atezo Study
This study is a prospective, two-arm, randomized phase II study of talazoparib versus talazoparib plus atezolizumab in ER+ premeonopausal women with metastatic breast cancer harboring HRD scar 1st line treatment: GnRH agonist +…
- Trial name
- Young-PALETTA (NCT04819243)
- Testing
- Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib, Atezolizumab, Pabociclib, Endocrine(or ET + CDK4/6 inhibitors), Talazoparib,
- Where
- South Korea
- Volunteers
- 178 people
- Sponsor
- Samsung Medical Center
ER+ Breast Cancer, HER2-negative Breast Cancer
A Trial of Early Detection of Molecular Relapse With Circulating Tumour DNA Tracking and Treatment With Palbociclib Plus Fulvestrant Versus Standard Endocrine Therapy in Patients With ER Positive HER2 Negative Breast Cancer
Detection of molecular relapse with circulating tumour DNA analysis can identify which patients with ER positive breast cancer are relapsing on adjuvant endocrine therapy.
- Trial name
- TRAK-ER (NCT04985266)
- Testing
- Palbociclib 125Mg Tab, Fulvestrant injection, Tamoxifen
- Where
- 49 sites in France, United Kingdom
- Volunteers
- 1,100 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Solid Tumor, Adult, Next-generation Sequencing
Study of Pazopanib Combined With Palbociclib for Refractory Solid Tumors With Co-amplified in the 11q13(FGF3/4/19/CCND1)
The efficacy and safety of Pazopanib combined with Palbociclib in the third line and above treatment of refractory solid tumors co amplified in the 11q13 region (FGF3/4/19/CCND1).
- Conditions
- Solid Tumor, Adult, Next-generation Sequencing, Precision Medicine
- Trial name
- NCT06895733
- Testing
- Pazopanib Oral Tablet, Palbociclib
- Where
- China
- Volunteers
- 65 people
- Sponsor
- Tianjin Medical University Second Hospital
Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial
This phase Ib trial is to find out the best dose, possible benefits and/or side effects of talazoparib when given in combination with palbociclib, axitinib, or crizotinib in treating patients with solid tumors that has spread to…
- Conditions
- Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
- Trial name
- NCT04693468
- Testing
- Axitinib, Crizotinib, Palbociclib Isethionate
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- M.D. Anderson Cancer Center
Inhibition of Autophagy Synergizes Anti-tumor Effect
A Phase Ib/II Study Confirmed Inhibition of Autophagy Synergizes Anti-tumor Effect of High Dose CDK4/6i
In order to explore the safety and antitumor efficacy of different doses of CDK4/6 inhibitor Palbociclib in combination with the autophagy inhibitor hydroxychloroquine (HCQ) , a phase Ib/II study was conducted.
- Trial name
- NCT05953350
- Testing
- 600mg bid dose of hydroxychloroquine combined with three predefined dose groups of palbociclib, RP2D dose of 600mg bid of hydroxychloroquine combined with palbociclib was selected for phase II clinical trial.
- Where
- China
- Volunteers
- 29 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
Advanced Solid Tumor, Advanced Breast Cancer
A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.
- Conditions
- Advanced Solid Tumor, Advanced Breast Cancer, Advanced Ovarian Cancer
- Trial name
- NCT06997029
- Testing
- BMS-986500, Palbociclib, Fulvestrant
- Where
- 21 sites in United States, Denmark and 1 more
- Volunteers
- 234 people
- Sponsor
- Bristol-Myers Squibb
Breast Cancer
Validation of Capillary Microsampling for Therapeutic Drug Monitoring of CDK4/6 Inhibitors in Breast Cancer Patients (TDHOME)
This is a prospective validation study, multicenter, open-label, single-arm study, evaluating the concordance between capillary microsampling (using the VAMS Mitra device) and venous sampling in patients undergoing CDK4/6 therapy.
- Trial name
- TDHOME (NCT07491380)
- Testing
- Capillary samples using the VAMS Mitra device
- Where
- 2 sites in France
- Volunteers
- 90 people
- Sponsor
- Institut Curie