Clinical trials: CDK4/6 Inhibitor
Early Breast Cancer
A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal…
- Trial name
- NATALEE (NCT03701334)
- Testing
- Ribociclib, Endocrine Therapy (ET)
- Where
- 387 sites in United States, Argentina and 18 more
- Volunteers
- 5,101 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
- Trial name
- MONALEESA-3 (NCT02422615)
- Testing
- Ribociclib, Fulvestrant
- Where
- 174 sites in United States, Australia and 28 more
- Volunteers
- 726 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm
Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors
This phase I trial studies the side effects and best dose of ribociclib and gemcitabine hydrochloride in treating patients with solid tumors that have spread to other places in the body.
- Trial name
- NCT03237390
- Testing
- Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 3 sites in United States
- Volunteers
- 43 people
- Sponsor
- Mayo Clinic
Breast Cancer
Initial CDK 4/6 Inhibitor Plus Endocrine Therapy Versus Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer
A multi-center, real world study to evaluate the clinical outcomes between initial CDK 4/6 Inhibitor plus endocrine therapy and initial chemotherapy in HR positive, HER2 negative unresectable or metastatic breast cancer.
- Trial name
- NCT06344793
- Where
- China
- Volunteers
- 608 people
- Sponsor
- Fudan University
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
Breast Cancer Metastatic
Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
- Trial name
- NCT05759572
- Testing
- Apatinib, Dalpiciclib, Fulvestrant/AI
- Where
- China
- Volunteers
- 145 people
- Sponsor
- Fudan University
Healthy Volunteers
Safety, Pharmacokinetic and Pharmacodynamic Study of the CDK 4/6 Inhibitor G1T28-1
This first-in-human (FIH) study will provide the first safety, PK, and PD data of G1T28-1 in humans and will allow further development of G1T28 1 in patients with cancer to reduce chemotherapy-induced myelosuppression.
- Trial name
- NCT02243150
- Testing
- G1T28-1 (CDK 4/6 Inhibitor)
- Where
- Netherlands
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- G1 Therapeutics, Inc.
Bladder Cancer
A Clinical Trail to Determine the Safety and Efficacy of the Combination of Tislelizumab With Cisplatin and Gemcitabine, With or Without Trilaciclib for Patients With Untreated Unresectable and Metastatic Urothelial Carcinoma.
The aim of this study is to see whether the Trilaciclib is safe and effective in slowing down the growth of bladder cancer in patients while taking chemoimmunotherapy.
- Trial name
- NCT06364904
- Testing
- Tislelizumab, Cisplatin, Gemcitabine and Trilaciclib, Tislelizumab, Cisplatin, Gemcitabine
- Where
- 8 sites in China
- Volunteers
- 210 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Advanced Breast Cancer
Chidamide Combined With Angiogenesis Inhibitors and Fulvestrant for Advanced HR-positive, HER2-negative Breast Cancer
This Phase Ⅱ study was designed to assess the efficacy and safety of the combination of tucidinostat, angiogenesis inhibitors and fulvestrant for advanced HR-positive, HER2-negative breast cancer patients after the failure of…
- Trial name
- NCT06750848
- Testing
- Chidamide，Fulvestrant，angiogenesis inhibitors
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Jundong Wu
Metastatic Breast Cancer
Utilizing Multiomic Advanced Diagnostics to Identify CDK 4/6 Inhibitor Response Predictors and a Post-treatment Multiomic Signature for Patients With ER+/HER2- Metastatic Breast Cancer
This is an open-label, multicenter study in patients with metastatic breast cancer who are candidates for standard first line treatment with palbociclib or ribociclib plus endocrine therapy.
- Trial name
- NCT03195192
- Testing
- biomarker study
- Where
- 8 sites in United States
- Volunteers
- 28 people
- Sponsor
- Side-Out Foundation
Breast Cancer
A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib
This study was a companion study to CLEE011A2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.
- Trial name
- NCT03050398
- Testing
- Ribociclib, letrozole
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
I/II Phase Study Evaluating M1774 in Combination With Fulvestrant in HR+ and HER2- Advanced Breast Cancers
CDK4/6 inhibitor in combination with endocrine treatment is the standard of care in advanced breast cancer (ABC) with expression of hormone receptors and without HER2 overexpression (ER+/HER2-).
- Trial name
- MATRIX (NCT05986071)
- Testing
- M1774, Fulvestrant injection
- Where
- France
- Volunteers
- 57 people
- Sponsor
- Institut Paoli-Calmettes
Esophageal Squamous Cell Carcinoma
Neoadjuvant Adebrelimab With Dalpiciclib for Resectable Esophageal Squamous Cell Carcinomas
The purpose of this study is to explore the safety and feasibility of anti-programmed cell death ligand 1(PD-L1) immunotherapy, Adebrelimab, combined with cyclin-dependent kinase 4/6 blockade, Dalpiciclib, as a new neoadjuvant…
- Trial name
- NCT06225921
- Testing
- Adebrelimab, Dalpiciclib 100mg, Dalpiciclib 150mg
- Where
- China
- Volunteers
- 6 people
- Sponsor
- West China Hospital
Breast Cancer
CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer
This research study is studying a drug as a possible treatment for ER-positive Breast Cancer The drug involved in this study is: -Ribociclib
- Trial name
- LEADER (NCT03285412)
- Testing
- Ribociclib, Endocrine therapy
- Where
- 3 sites in United States
- Volunteers
- 120 people
- Sponsor
- Massachusetts General Hospital
Head and Neck Squamous Cell Carcinoma
Neoadjuvant Adebrelimab Plus Dalpiciclib in Head and Neck Squamous Cell Carcinoma
This study is a single arm phase II trial including 30 patients with III-IVB (according to the 8th edition of UICC/AJCC staging) locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection, who receive…
- Trial name
- NCT06199271
- Testing
- Adebrelimab and dalpiciclib
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Zhongzheng Xiang
Breast Cancer
Neoadjuvant Dalpiciclib Plus Letrozole for HR+/HER2- Breast Cancer
In this single arm, open label, phase 2 trial, operable patients with stage IIB-III HR+/HER2- breast cancer will be enrolled and receive six cycles of adjuvant dalpiciclib plus letrozole.
- Trial name
- NCT05512416
- Testing
- dalpiciclib plus letrozole
- Volunteers
- 35 people
- Sponsor
- The Affiliated Hospital of Qingdao University
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
Leukemia, Lymphocytic, Lymphoblastic Lymphoma
Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL)
AINV18P1 is a Phase 1 study where palbociclib will be administrated in combination with a standard re-induction platform in pediatric relapsed Acute Lymphoblastic Leukemia (ALL) and lymphoblastic lymphoma (LL).
- Conditions
- Leukemia, Lymphocytic, Lymphoblastic Lymphoma, T-cell Lymphoma, T-cell Leukemia
- Trial name
- NCT03792256
- Testing
- Palbociclib, Cytarabine, Methotrexate
- Where
- 19 sites in United States
- Volunteers
- 12 people
- Sponsor
- Children's Oncology Group
Metastatic Breast Cancer
Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer
To demonstrate the efficacy of enobosarmin the treatment of androgen receptor positive (AR+) and estrogen receptor positive (ER+) metastatic breast cancer (MBC) as measured by radiographic progression free survival (rPFS).
- Trial name
- ARTEST (NCT04869943)
- Testing
- Enobosarm, Exemestane
- Where
- 54 sites in United States, Poland and 2 more
- Volunteers
- 52 people
- Sponsor
- Veru Inc.
Breast Cancer
Adjuvant CDK4/6 Inhibitor Use in HR+/HER2- Breast Cancer
To evaluate the efficacy and safety of adjuvant CDK4/6 inhibitors in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.
- Trial name
- NCT07180056
- Testing
- CDK4/6 inhibitor
- Where
- China
- Volunteers
- 229 people
- Sponsor
- Wenjin Yin