Clinical trials: CDK4/6 Inhibitor
Non-small Cell Lung Carcinoma, Head and Neck Squamous Cell Carcinoma
Phase Ib Study of TNO155 in Combination With Spartalizumab or Ribociclib in Selected Malignancies
This study was a Phase Ib, multi-center, open-label study of TNO155 in combination with spartalizumab or ribociclib with a dose escalation part followed by a dose expansion part in adult subjects with advanced solid tumors.
- Conditions
- Non-small Cell Lung Carcinoma, Head and Neck Squamous Cell Carcinoma, Esophageal SCC, Gastrointestinal Stromal Tumors
- Trial name
- NCT04000529
- Testing
- TNO155, Spartalizumab, Ribociclib
- Where
- 10 sites in United States, Australia and 7 more
- Volunteers
- 122 people
- Sponsor
- Novartis Pharmaceuticals
Non Small Cell Lung Cancer, Glioma Glioblastoma Multiforme
Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
This is a first in human study of TNG456 alone and in combination with abemaciclib in patients with advanced or metastatic solid tumors known to have an MTAP loss.
- Conditions
- Non Small Cell Lung Cancer, Glioma Glioblastoma Multiforme, Glioma, Malignant, Solid Tumor
- Trial name
- NCT06810544
- Testing
- TNG456, abemaciclib
- Where
- 15 sites in United States
- Volunteers
- 191 people
- Sponsor
- Tango Therapeutics, Inc.
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
Breast Cancer
A Phase II Clinical Study of the Efficacy and Safety of Culmerciclib Rechallenge in HR-positive, HER2-negative Breast Cancer Patients With Resistance to First-line Endocrine Therapy.
To evaluate the efficacy and safety of Culmerciclib combined with fulvestrant compared with investigator-selected CDK4/6 inhibitors combined with fulvestrant in patients with HR-positive/HER2-negative breast cancer who have…
- Trial name
- NCT07666555
- Testing
- CDK4/6 inhibitor, Culmerciclib, Fulvestrant
- Where
- China
- Volunteers
- 98 people
- Sponsor
- Fudan University
Digestive System Tumors
Study of CDK4/6 Inhibitor Combined With PD-L1 Monoclonal Antibody in the Treatment of PD-1/PD-L1 Resistance and Abnormal Cell Cycle Digestive System Tumors
This study intends to explore the effectiveness and safety of CDK4/6 inhibitor (TQB3616) combined with PD-L1 monoclonal antibody (TQB2450) in the treatment of PD-1/PD-L1 monoclonal antibody resistance and abnormal cell cycle…
- Trial name
- NCT05139082
- Testing
- TQB3616 capsules＋ TQB2450 injection
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Peking University
Brest Cancer, CDK4/6 Inhibitor
Effectiveness and Safety of Palbociclib: Brand vs. Generic in Iraqi Stage IV Breast Cancer Patients
This study aims to evaluate the efficacy and safety of branded palbociclib (Ibrance®) compared to available local generic formulations (Palbociclib-IPI) in Iraqi patients with hormone receptor-positive, human epidermal growth…
- Trial name
- PALLAS-IRAQ (NCT07493291)
- Testing
- Palbociclib (Brand vs Generic) compartive
- Where
- Iraq
- Volunteers
- 100 people
- Sponsor
- Al-Mustansiriyah University
Myelofibrosis
Study of the Safety of PIM447 in Combination With Ruxolitinib (INC424) and LEE011 in Patients With Myelofibrosis
This is a phase Ib study with the primary purpose is to estimate the MTD and/or RDE for the triple combination of PIM447, formerly LGH447, plus ruxolitinib and LEE011 as well as for the doublets, PIM447 plus ruxolitinib, and…
- Trial name
- NCT02370706
- Testing
- PIM447, Ruxolitinib, LEE011
- Where
- 9 sites in Australia, Canada and 6 more
- Volunteers
- 15 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor
The purpose of this study is to find out whether a new drug, Ipatasertib, can slow the growth of advanced breast cancer when added to standard therapy (Fulvestrant).
- Trial name
- FINER (NCT04650581)
- Testing
- Ipatasertib, Fulvestrant
- Where
- 39 sites in Australia, Canada and 1 more
- Volunteers
- 250 people
- Sponsor
- Canadian Cancer Trials Group
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
Breast Cancer
Pyrotinib Combined With Trastuzumab,Dalpiciclib and Letrozole for HR+/HER2+ Breast Cancer
In this single arm, open label, phase 2 trial, operable patients with stage II-III HR+/HER2+ breast cancer will be enrolled and receive two cycles of pyrotinib combined with trastuzumab, dalpiciclib and letrozole.
- Trial name
- NCT05800756
- Testing
- pyrotinib combined with trastuzumab, dalpiciclib and letrozole
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Yantai Yuhuangding Hospital
Breast Cancer, Metastatic, Metastatic Breast Cancer
Stereotactic Ablative Body Radiotherapy (SABR) With Maintenance of Systemic Therapy Versus Physicians' Choice of Systemic Therapy for Oligoprogressive ER-positive, Her-2 Negative Breast Cancer II
The goal of this clinical trial is to assess Stereotactic Ablative Radiotherapy (SABR) as a method to delay a change in systemic therapy in patients with oligoprogressive ER-positive, HER2-negative advanced breast cancer.
- Trial name
- AVATARII (NCT06882499)
- Testing
- Stereotactic Ablative Radiotherapy, Physician's choice of systemic treatment
- Volunteers
- 74 people
- Sponsor
- Peter MacCallum Cancer Centre, Australia
Breast Cancer
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments
This was a Phase II, multicenter, open-label, three-cohort, non-comparative study of alpelisib plus endocrine therapy (either fulvestrant or letrozole) in subjects (pre- and post-menopausal women and men) with HR-positive…
- Trial name
- BYLieve (NCT03056755)
- Testing
- Alpelisib, Fulvestrant, Letrozole
- Where
- 94 sites in United States, Argentina and 17 more
- Volunteers
- 383 people
- Sponsor
- Novartis Pharmaceuticals
HR+/HER2- Advanced/Metastatic Breast Cancer
Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitors
A randomized, double-blind, multicenter phase III clinical study to evaluate the efficacy and safety of sirolimus for injection (albumin-bound) combined with fulvestrant in patients with HR+ and HER2- advanced breast cancer.
- Trial name
- NCT06929325
- Testing
- Sirolimus for Injection (Albumin-bound), Fulvestrant Injection
- Where
- China
- Volunteers
- 312 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Advanced HR+ HER2 Negative Breast Carcinoma
H (Trastuzumab or Biosimilar) Combined With CDK4/6 Inhibitor + AI±OFS in the Treatment of HR+HER2+ Advanced Breast Cancer Efficacy and Safety: a Chinese Multi-center Real World Study
This study is a multi-center prospective real-world clinical study, mainly evaluating the efficacy and safety of H combined with CDK4/6 inhibitor + AI in the treatment of HR+/HER2+ advanced breast cancer; exploring potential…
- Trial name
- NCT05167643
- Testing
- Enituzumab injection+Abesili tablets+Anastrozole tablets
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
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
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
Locally Advanced or Metastatic Breast Cancer
A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain
The purpose of this study is to evaluate the effectiveness and safety of capivasertib + fulvestrant treatment administration in patients with locally advanced (inoperable) or metastatic HR+ / HER2- breast cancer with…
- Trial name
- CAPItana (NCT06764186)
- Testing
- Fulvestrant, Capivasertib
- Where
- 17 sites in Spain
- Volunteers
- 101 people
- Sponsor
- AstraZeneca
Breast Cancer Metastatic
PARP Inhibitor With CDK4/ 6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer
This study is a prospective, open-label, phase III clinical study for patients with HR+/HER2- advanced breast cancer.
- Trial name
- NCT06612814
- Testing
- Fluzoparib, Dalpiciclib, Fulvestrant/AI
- Where
- China
- Volunteers
- 307 people
- Sponsor
- Zhimin Shao
Colorectal Cancer Metastatic, Myelosuppression-Adult
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):
This was a randomized, double-blind, placebo-controlled, global, multicenter, Phase 3 trial evaluating the impact of trilaciclib on myelopreservation and anti-tumor efficacy when administered prior to FOLFOXIRI/bevacizumab in…
- Conditions
- Colorectal Cancer Metastatic, Myelosuppression-Adult, Chemotherapeutic Toxicity
- Trial name
- PRESERVE1 (NCT04607668)
- Testing
- Trilaciclib
- Where
- 82 sites in United States, China and 6 more
- Volunteers
- 326 people
- Sponsor
- G1 Therapeutics, Inc.
Head and Neck Squamous Cell Carcinoma
A Phase II Study of Anti-EGFR Antibody-drug Conjugate (ADC) Combine With CDK4/6 Inhibitors Posterior Line in the Treatment of Recurrent/Metastatic CDKN2A Gene Variant Head and Neck Squamous Cell Carcinoma
A Single-arm, Phase II Study of MRG003 combined with Dalpicicilip posterior line in the treatment of recurrent/metastatic CDKN2A gene variant head and neck squamous cell carcinoman (HNSCC).
- Trial name
- NCT06509997
- Testing
- MRG003 combined with Dalpicicilip
- Volunteers
- 30 people
- Sponsor
- Lei Liu