Clinical trials: CDK4/6 Inhibitor
Advanced Breast Cancer, Treatment-Refractory Solid Tumors
TAS-116 Plus Palbociclib in Breast and Rb-null Cancer
The purpose of this study is to evaluate the safety and efficacy of TAS-116 with palbociclib in two groups of patients: Patients with advanced breast cancer that has become worse after taking palbociclib alone Patients with…
- Conditions
- Advanced Breast Cancer, Treatment-Refractory Solid Tumors, Retinoblastoma Deficiency, SCLC
- Trial name
- NCT05655598
- Testing
- Palbociclib Oral Product, TAS-116
- Where
- United States
- Sponsor
- Brown University
Metastatic Pancreatic Ductal Adenocarcinoma
Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC
This is a Phase 1, open label, multi center, multiple dose, dose escalation, safety, pharmacokinetic and pharmacodynamic study of palbociclib in combination with nab-P, in sequential cohorts of adult patients with mPDAC, with MTD…
- Trial name
- NCT02501902
- Testing
- Palbociclib, Nab-Paclitaxel
- Where
- 26 sites in United States, Spain
- Volunteers
- 76 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body
The reason for this study is to determine the recommended phase 2 dose of the study drug LY3295668 erbumine in participants with breast cancer that has spread to other parts of the body.
- Trial name
- NCT03955939
- Testing
- LY3295668 Erbumine, Endocrine therapy, Midazolam
- Where
- 7 sites in United States, Belgium
- Volunteers
- 5 people
- Sponsor
- Eli Lilly and Company
Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8
Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer
This phase II trial studies how well binimetinib and palbociclib work compared to TAS-102 in treating patients with KRAS and NRAS mutation positive colorectal cancer that has spread to other places in the body (metastatic) or…
- Conditions
- Metastatic Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8
- Trial name
- NCT03981614
- Testing
- Binimetinib, Palbociclib, Trifluridine and Tipiracil Hydrochloride
- Where
- 7 sites in United States
- Volunteers
- 102 people
- Sponsor
- Academic and Community Cancer Research United
Advanced Breast Cancer, ER-positive Breast Cancer
Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.
This trial will study a type of advanced breast cancer (ABC) defined as endocrine receptor (ER)-positive/human epidermal growth factor receptor 2(HER2)-negative and estrogen receptor 1 (ESR1)-mutated.
- Conditions
- Advanced Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, ESR1 Gene Mutation
- Trial name
- ADELA (NCT06382948)
- Testing
- Everolimus, Elacestrant, Auxiliary Medicinal Product - Dexamethasone
- Where
- 104 sites in Austria, Brazil and 7 more
- Volunteers
- 300 people
- Sponsor
- MedSIR
Estrogen Receptor-positive (ER+)/Human Epidermal Growth Factor Receptor (HER2)-Negative Locally Advanced or Metastatic Breast Cancer
A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy
This is a Phase II, multicenter, open-label, randomized study to compare the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone in women with ER+, HER2-negative, locally advanced or Metastatic…
- Trial name
- Veronica (NCT03584009)
- Testing
- Venetoclax, Fulvestrant
- Where
- 40 sites in United States, Australia and 3 more
- Volunteers
- 103 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
The purpose of this study is to learn about the safety and effects of the study medicine PF-07248144 when given along with fulvestrant for the possible treatment of HR-positive, HER2-negative advanced or metastatic breast cancer.
- Trial name
- NCT07062965
- Testing
- PF-07248144, Fulvestrant, Everolimus
- Where
- 433 sites in United States, Argentina and 29 more
- Volunteers
- 400 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
Pembrolizumab + Paclitaxel in HR+/HER2- Non-luminal (by PAM50) Advanced Breast Cancer After CDK4/6 Inhibitor Progression
This is an open-label, single arm, multicenter phase II study evaluating treatment with pembrolizumab in combination with paclitaxel in patients with locally advanced or metastatic non-luminal hormone receptor-positive (HR+)…
- Trial name
- TATEN (NCT04251169)
- Testing
- Pembrolizumab, Paclitaxel
- Where
- 7 sites in Spain
- Volunteers
- 20 people
- Sponsor
- SOLTI Breast Cancer Research Group
Advanced Breast Cancer
Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
The purpose of this study is to learn if certain drug combinations are effective treatments for patients with advanced ER+/HER2- who have previously been treated with palbociclib, ribociclib, or abemaciclib.
- Trial name
- GERTRUDE (NCT05933395)
- Testing
- Fulvestrant, Neratinib, Alpelisib
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Breast Cancer Female
PreOperative Endocrine Therapy for Individualised Care With Abemaciclib
POETIC-A is a phase 3 trial which targets post-menopausal primary breast cancer patients with a high 5-year risk of relapse as determined by a high Ki67 after 2 weeks aromatase inhibitor therapy pre-surgery.
- Trial name
- POETIC-A (NCT04584853)
- Testing
- Abemaciclib, Endocrine therapy (letrozole, anastrozole, exemestane or tamoxifen)
- Where
- 62 sites in United Kingdom
- Volunteers
- 123 people
- Sponsor
- Institute of Cancer Research, United Kingdom
Anaplastic Astrocytoma, Anaplastic Ependymoma
SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors
Approximately 90% of children with malignant brain tumors that have recurred or relapsed after receiving conventional therapy will die of disease.
- Conditions
- Anaplastic Astrocytoma, Anaplastic Ependymoma, Anaplastic Ganglioglioma, Anaplastic Meningioma
- Trial name
- NCT03434262
- Testing
- Gemcitabine, ribociclib, sonidegib
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- St. Jude Children's Research Hospital
Lung Cancer Squamous Cell, Solid Tumors
Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors
This research study is studying a combination of drugs as a possible treatment for cancer that might have a specific change in the phosphatidylinositol-3 phosphate (PI3K) pathway.
- Conditions
- Lung Cancer Squamous Cell, Solid Tumors, Head & Neck Cancer, Pancreatic Cancer
- Trial name
- NCT03065062
- Testing
- Palbociclib, Gedatolisib
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer, Metastatic Breast Cancer
Prognostic Impact of the Neutrophil/Lymphocyte Ratio (NLR) in the Treatment of First-line Metastatic or Locally Advanced Breast Cancer Treated With CDK4/6 Inhibitor.
The impact of the inflammatory microenvironment in predicting the benefit of a CDK4/6 inhibitor in the treatment of locally advanced or first line metastatic breast cancer has not yet been studied.
- Trial name
- PEPSI (NCT05303129)
- Testing
- Blood sampling
- Where
- 2 sites in France
- Volunteers
- 165 people
- Sponsor
- Centre Francois Baclesse
Breast Cancer
Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at…
- Trial name
- EMERALD (NCT03778931)
- Testing
- Elacestrant, Standard of Care
- Where
- 244 sites in United States, Argentina and 15 more
- Volunteers
- 478 people
- Sponsor
- Stemline Therapeutics, Inc.
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor…
- Trial name
- INAVO121 (NCT05646862)
- Testing
- Inavolisib, Fulvestrant, Alpelisib
- Where
- 210 sites in United States, Argentina and 18 more
- Volunteers
- 420 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Real-World Study of Early Breast Cancer Patients Eligible for Treatment With CDK4/6 Inhibitors
The aim of this study was to describe treatment patterns, patient characteristics and clinical outcomes among hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) early breast cancer (eBC)…
- Trial name
- LEEWARD (NCT07647042)
- Where
- United States
- Volunteers
- 750 people
- Sponsor
- Novartis Pharmaceuticals
Solid Tumor, Advanced Solid Tumor
A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
The goal of the Monotherapy Dose Escalation phase (Part 1) of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for…
- Conditions
- Solid Tumor, Advanced Solid Tumor, Solid Tumor, Adult, Metastatic Tumor
- Trial name
- NCT06586957
- Testing
- NKT3964, Paclitaxel, Doxorubicin
- Where
- 20 sites in United States, South Korea
- Volunteers
- 238 people
- Sponsor
- NiKang Therapeutics, Inc.
Breast Cancer, Advanced Breast Cancer
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one…
- Conditions
- Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer
- Trial name
- OPERA-01 (NCT06016738)
- Testing
- Palazestrant, Fulvestrant, Anastrozole
- Where
- 233 sites in United States, Argentina and 24 more
- Volunteers
- 510 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Nasopharyngeal Carcinoma
CDK4/6 Inhibitor Plus Camrelizumab for PD-1 Inhibitor Refractory R/M NPC
Because most patients with R/M NPC have received long-term maintenance of immunotherapy at the time of initial treatment and the first-line treatment, there are a large number of PD-1 inhibitor refractory patients.
- Trial name
- NCT05724355
- Testing
- Dalpiciclib Isetionate Tablets, Camrelizumab
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Sun Yat-sen University
Head and Neck Squamous Cell Carcinoma
Neoadjuvant Camrelizumab With Dalpiciclib for Resectable Head and Neck Squamous Cell Carcinomas
The purpose of this study is to explore the safety and feasibility of anti-programmed cell death protein 1(PD-1) immunotherapy, Camrelizumab, combined with cyclin-dependent kinase 4/6 blockade, Dalpiciclib, as a new neoadjuvant…
- Trial name
- NCT06109207
- Testing
- Camrelizumab, Dalpiciclib 100mg, Dalpiciclib 150mg
- Where
- China
- Volunteers
- 6 people
- Sponsor
- West China Hospital