Clinical trials: Palbociclib
Receptors, Estrogen, Genes, Erbb-2
A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer
The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2…
- Conditions
- Receptors, Estrogen, Genes, Erbb-2, Breast Neoplasms
- Trial name
- NCT04288089
- Testing
- Palbociclib (75, 100, 125 milligram [mg]), H3B-6545 (150, 300, 450 mg)
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 31 people
- Sponsor
- Eisai Inc.
Breast Neoplasms
A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]
The study is designed to compare the clinical benefit following treatment with letrozole in combination with Palbociclib versus letrozole in combination with placebo in Asian postmenopausal women with ER(+)/HER2(-) advanced…
- Trial name
- NCT02297438
- Testing
- Palbociclib, Letrozole
- Where
- 54 sites in China, Hong Kong and 3 more
- Volunteers
- 340 people
- Sponsor
- Pfizer
Solid Tumor, Lymphoma
ALRN-6924 in Patients With Advanced Solid Tumors or Lymphomas
This study evaluates the anti-tumor effects of ALRN-6924 in patients with advanced solid tumors or lymphomas with WT TP53.
- Conditions
- Solid Tumor, Lymphoma, Peripheral T-Cell Lymphoma
- Trial name
- NCT02264613
- Testing
- ALRN-6924
- Where
- 13 sites in United States
- Volunteers
- 142 people
- Sponsor
- Aileron Therapeutics, Inc.
Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)
This phase II Pediatric MATCH screening and multi-sub-trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have…
- Conditions
- Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Histiocytic Sarcoma
- Trial name
- NCT03155620
- Testing
- Biopsy Procedure, Biospecimen Collection, Bone Marrow Aspiration and Biopsy
- Where
- 172 sites in United States, Australia and 2 more
- Volunteers
- 1,377 people
- Sponsor
- National Cancer Institute (NCI)
Metastatic Breast Cancer
Comparative Real World Tumor Response in Pre-menopausal Metastatic Breast Cancer Patients Treated With Palbociclib + Aromatase Inhibitor or Aromatase Inhibitor Alone
This study aims to assess real-world tumor response in pre/perimenopausal HR+/HER2- metastatic breast cancer (MBC) patients initiating palbociclib + aromatase inhibitor (AI) or AI alone as first-line therapy during the period on…
- Trial name
- NCT05012644
- Testing
- Palbociclib + aromatase inhibitor, Aromatase inhibitor
- Where
- United States
- Volunteers
- 197 people
- 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
Breast Cancer, Breast Carcinoma
Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer
The investigators propose to conduct a study to test an alternative dosing schedule of palbociclib. With the current three-week on and one week off schedule, a significant number of patients develop grade 3 or higher degree of…
- Conditions
- Breast Cancer, Breast Carcinoma, Cancer of Breast, Malignant Tumor of Breast
- Trial name
- NCT03007979
- Testing
- Palbociclib, Letrozole, Fulvestrant
- Where
- 2 sites in United States
- Volunteers
- 55 people
- Sponsor
- Washington University School of Medicine
Early Breast Cancer
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)
This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the window-of-opportunity phase) and giredestrant plus…
- Trial name
- NCT04436744
- Testing
- Giredestrant, Anastrozole, Palbociclib
- Where
- 65 sites in United States, Australia and 9 more
- Volunteers
- 221 people
- Sponsor
- Hoffmann-La Roche
Ewing Sarcoma, Solid Tumors
Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults…
- Conditions
- Ewing Sarcoma, Solid Tumors, Rhabdoid Tumor, Rhabdomyosarcoma
- Trial name
- NCT03709680
- Testing
- Palbociclib, Temozolomide, Irinotecan
- Where
- 84 sites in United States, Brazil and 11 more
- Volunteers
- 128 people
- Sponsor
- Pfizer
HER-2 Positive Breast Cancer, Estrogen Receptor Positive Breast Cancer
Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer
The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes…
- Trial name
- PATINA (NCT02947685)
- Testing
- palbociclib, trastuzumab, pertuzumab
- Where
- 108 sites in United States, Australia and 6 more
- Volunteers
- 518 people
- Sponsor
- Alliance Foundation Trials, LLC.
Estrogen Receptor-positive Breast Cancer, HER2/Neu Negative
Testing the Effects of Palbociclib and Fulvestrant or Letrozole for Patients 70 Years of Age of Older With Metastatic Breast Cancer
This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to…
- Conditions
- Estrogen Receptor-positive Breast Cancer, HER2/Neu Negative, Stage IV Breast Cancer AJCC v6 and v7
- Trial name
- NCT03633331
- Testing
- Palbociclib, Letrozole, Fulvestrant
- Where
- 447 sites in United States
- Volunteers
- 93 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Head and Neck Squamous Cell Carcinoma
Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma
The purpose of this study is to evaluate the results of treating patients with HPV-unrelated head and neck squamous cell carcinoma with neoadjuvant single-agent palbociclib, followed by chemoradiation (either cisplatin + IMRT or…
- Trial name
- NCT03389477
- Testing
- Palbociclib, Cetuximab, Cisplatin
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Washington University School of Medicine
Metastatic Breast Cancer
Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib
To assess longitudinal changes in allele frequency of ESR1 mutation in plasma in patients treated with Fulvestrant plus palbociclib compared to tamoxifen plus palbociclib
- Trial name
- NCT02913430
- Testing
- Fulvestrant, Tamoxifen, Palbociclib
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Shannon Puhalla
Metastatic Breast Cancer
Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors
This is an international (4 countries) randomized phase III study with 2 cohorts, patients will be randomized 1:1 to endocrine therapy (cohort 1: exemestane 25 mg daily, cohort 2: fulvestrant 500mg days 1 and 15 cycle 1 and then…
- Trial name
- PEARL (NCT02028507)
- Testing
- Palbociclib, Capecitabine, Exemestane
- Where
- 37 sites in Austria, Hungary and 2 more
- Volunteers
- 693 people
- Sponsor
- Spanish Breast Cancer Research Group
Breast Cancer, Breast Carcinoma
A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer
This study will look at effects the combination of palbociclib and letrozole may have on estrogen receptor (ER)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer tumors which have not yet been…
- Conditions
- Breast Cancer, Breast Carcinoma, Breast Tumors
- Trial name
- PALLET (NCT02296801)
- Testing
- Letrozole, palbociclib
- Where
- 52 sites in United States, Canada and 1 more
- Volunteers
- 307 people
- Sponsor
- NSABP Foundation Inc
Advanced Hepatocellular Carcinoma, HCC
A Clinical Research Study to Determine Whether PD 0332991 May Be Effective in Treating Patients With Liver Cancer
This is a Phase 2 Study of PD-0332991 in the treatment of patients with Advanced Hepatocellular Carcinoma (HCC), a type of adenocarcinoma and the most common type of liver tumor.
- Conditions
- Advanced Hepatocellular Carcinoma, HCC, Liver Cancer
- Trial name
- NCT01356628
- Testing
- PD-0332991
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
CCND1 Gene Amplification, CCND2 Gene Amplification
Lung-MAP: Palbociclib as Second-Line Therapy in Treating Cell Cycle Gene Alteration Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer
This phase II/III trial studies how well palbociclib works in treating cell cycle gene alteration positive patients with stage IV squamous cell lung cancer that has come back after previous treatment.
- Conditions
- CCND1 Gene Amplification, CCND2 Gene Amplification, CCND3 Gene Amplification, CDK4 Gene Amplification
- Trial name
- NCT02785939
- Testing
- Docetaxel, Laboratory Biomarker Analysis, Palbociclib
- Where
- 1,065 sites in United States
- Volunteers
- 53 people
- Sponsor
- SWOG Cancer Research Network
Carcinoma, Squamous Cell of Head and Neck
PD 0332991 and Cetuximab in Patients With Incurable SCCHN
The purpose of this Phase I/II study is to define the maximum tolerated dose of PD 0332991 given with cetuximab and evaluated the side effects of the combination.
- Trial name
- NCT02101034
- Testing
- Cetuximab, PD 0332991
- Where
- 5 sites in United States
- Volunteers
- 96 people
- Sponsor
- Washington University School of Medicine
Breast Cancer
Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer
A study of palbociclib in combination with letrozole as treatment of post-menopausal women with hormone receptor-positive, her2-negative advanced breast cancer for whom letrozole therapy is deemed appropriate.
- Trial name
- NCT02679755
- Testing
- Palbociclib, Letrozole
- Where
- 34 sites in Australia, India
- Volunteers
- 252 people
- Sponsor
- Pfizer
Ewing Sarcoma, Ewing's Sarcoma Recurrent
Palbociclib + Ganitumab In Ewing Sarcoma
This research study is designed to study the combination of two drugs, palbociclib and ganitumab, as a potential treatment for Ewing sarcoma. The names of the study drugs involved in this study are: Palbociclib Ganitumab
- Trial name
- NCT04129151
- Testing
- Palbociclib, Ganitumab
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Dana-Farber Cancer Institute