Clinical trials: CDK4/6 Inhibitor
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
Breast Cancer
Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer
This study is being done to answer the following question: Can testing breast cancer for DNA abnormalities or "biomarkers" help predict which patients are most likely to be helped by certain treatments? The pre-study screening is…
- Trial name
- NCT05601440
- Testing
- RP-6306, Gemcitabine, Observation
- Where
- 10 sites in Canada
- Volunteers
- 484 people
- Sponsor
- Canadian Cancer Trials Group
Breast Cancer
Artificial Intelligence and Machine Learning to Guide CDK4/6 Inhibitor Rechallenge in Breast Cancer.
The goal of this clinical trial is to learn if an artificial intelligence model will be able to select patients with advanced breast cancer who may respond to a second cyclin-dependent kinase 4/6 (CDK4/6) inhibitor after they…
- Trial name
- AIM-BRIGHT (NCT07227233)
- Testing
- A CDK4/6 inhibitor different from the first that the participant had received, plus fulvestrant., Treatment of physician's choice
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- University of California, San Diego
Advanced HR+ HER2 Negative Breast Carcinoma
Advanced Breast Cancer Study of CDK4/6 Inhibitor Combined With Endocrine Therapy Endocrine Therapy in HR+/HER2- Advanced Breast Cancer
By retrospectively collecting and arranging real-world data of multi-center HR+/HER2- advanced breast cancer in China combined with CDK4/6 inhibitor and endocrine therapy, we analyzed different HER2 expression levels (HER2 0, 1+…
- Trial name
- NCT05295043
- Testing
- (CDK)4/6 inhibitor
- Volunteers
- 500 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype.
- Conditions
- Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer, Advanced Breast Cancerv, Metastatic Breast Cancer
- Trial name
- NCT06062498
- Testing
- elacestrant, palbociclib, abemaciclib, ribociclib
- Where
- 3 sites in United States
- Volunteers
- 174 people
- Sponsor
- Northwestern University
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
CRC, HCC
A Trial of SHR-1210 in Combination With SHR6390 in Patients With Advanced CRC, NSCLC and HCC
This is a Phase Ib/II , Open-label , Investigator-initiated Trail of SHR-1210 (an Anti-PD-1 Inhibitor) in Combination With SHR6390 (a CDK4/6 Inhibitor) in Patients With Advanced Colorectal Cancer, Non-small Cell Lung Cancer and…
- Conditions
- CRC, HCC, NSCLC
- Trial name
- NCT03601598
- Testing
- SHR-1210, SHR6390
- Volunteers
- 41 people
- Sponsor
- Harbin Medical University
Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma
Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer
This phase II trial studies how well abemaciclib works in treating patients with ovarian or endometrial cancer that has an activation of the CDK4/6 pathway and that has come back (recurrent).
- Conditions
- Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
- Trial name
- NCT04469764
- Testing
- Abemaciclib, Anastrozole, Letrozole
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Jonsson Comprehensive Cancer Center
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
Solid Tumor, Solid Tumor, Adult
A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors
The goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, and pharmacokinetics (PK) to determine the maximum tolerated dose (MTD) and/or preliminary recommended dose for expansion (RDE) of…
- Conditions
- Solid Tumor, Solid Tumor, Adult, Advanced Solid Tumor, Metastatic Tumor
- Trial name
- NCT06264921
- Testing
- NKT3447
- Where
- 8 sites in United States
- Volunteers
- 23 people
- Sponsor
- NiKang Therapeutics, Inc.
PIK3CA Mutation, HER2- Negative Breast Cancer
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with…
- Conditions
- PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer
- Trial name
- ReDiscover-2 (NCT06982521)
- Testing
- Zovegalisib, Capivasertib, Fulvestrant
- Where
- 243 sites in United States, Argentina and 25 more
- Volunteers
- 540 people
- Sponsor
- Relay Therapeutics, Inc.
Advanced Breast Cancer, Treatment
Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase Ⅱ Clinical Trial
To observe the differences in the efficacy of Combination followed by maintenance chemotherapy versus CDK4/6 inhibitor combined with endocrine therapy in HR low expression /HER2 negative advanced breast cancer, and to provide new…
- Conditions
- Advanced Breast Cancer, Treatment, HR Low/HER2 Negative
- Trial name
- NCT06176534
- Testing
- Experimental: chemotheyapy, Active Comparator: endocrine therapy
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer
Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.
The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is safe and effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6…
- Trial name
- TRINITI-1 (NCT02732119)
- Testing
- Ribociclib, Everolimus, Exemestane
- Where
- 25 sites in United States
- Volunteers
- 104 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer Metastatic
Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer
This is a multicenter, prospective, randomized, open-label, controlled phase II study to test the addition of the CDK4/6 inhibitor ribociclib to anti-hormonal treatment as maintenance therapy in patients with disease control (at…
- Trial name
- AMICA (NCT03555877)
- Testing
- Ribociclib, Anastrozole, Letrozole
- Where
- Germany
- Volunteers
- 56 people
- Sponsor
- GBG Forschungs GmbH
HR+/HER2- Advanced Breast Cancer
Exploration of Dalpiciclib Plus HDACi in HR+/HER2- Advanced Breast Cancer After Failure of CDK4/6 Inhibitor
A phase II study to explore the efficacy and safety of dalpiciclib plus HDACi in HR+/HER2- advanced breast cancer after the failure of CDK4/6 inhibitor therapy.
- Trial name
- NCT06556862
- Testing
- Dalpiciclib, Chidamide, Enitinostat
- Where
- China
- Volunteers
- 155 people
- Sponsor
- Beijing 302 Hospital
Advanced Solid Tumor
A Study of HS-10342 in Patients With Advanced Solid Tumor
HS-10342 is a small molecular, oral potent, selective CDK4/6 inhibitor. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic profile of HS-10342 in Chinese advanced solid tumor patients.
- Trial name
- NCT04060511
- Testing
- HS-10342
- Where
- 5 sites in China
- Volunteers
- 17 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Small Cell Lung Cancer
Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK4/6 Inhibitor, in Extensive-Stage SCLC
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing antitumor efficacy when administered with carboplatin, etoposide, and…
- Trial name
- NCT03041311
- Testing
- Trilaciclib, Carboplatin, Etoposide
- Where
- 45 sites in United States, Bulgaria and 5 more
- Volunteers
- 107 people
- Sponsor
- G1 Therapeutics, Inc.
Breast Cancer Metastatic, Estrogen Receptor-positive Breast Cancer
Personalised Disease Monitoring in Metastatic Breast Cancer
Patients with metastatic breast cancer may respond well to treatment and metastases can remain stable for several years. Despite personalised medicine being increasingly used for diagnosis and treatment, follow-up still include…
- Trial name
- PDM-MBC (NCT04597580)
- Where
- 7 sites in Sweden, United Kingdom
- Volunteers
- 97 people
- Sponsor
- The Christie NHS Foundation Trust
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
Breast Cancer
Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer
This clinical trial will assess the safety and early efficacy of Hydroxychloroquine or Avelumab, with or without Palbociclib, in early-stage ER+ breast cancer patients who are found to harbor disseminated tumor cells (DTCs) in…
- Trial name
- PALAVY (NCT04841148)
- Testing
- HCQ, Avelumab, Palbociclib
- Where
- 7 sites in United States
- Volunteers
- 96 people
- Sponsor
- Abramson Cancer Center at Penn Medicine