Clinical trials: CDK4/6 Inhibitor
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.
Urothelial Carcinoma, Bladder Cancer
Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab
This is a Phase 2, multicenter, randomized, open-label study evaluating the safety and efficacy of trilaciclib administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy…
- Conditions
- Urothelial Carcinoma, Bladder Cancer, Myelosuppression Adult, Chemotherapy-induced Neutropenia
- Trial name
- PRESERVE3 (NCT04887831)
- Testing
- Trilaciclib, Gemcitabine, Cisplatin
- Where
- 34 sites in United States, France and 3 more
- Volunteers
- 92 people
- Sponsor
- G1 Therapeutics, Inc.
Breast Cancer, Fulvestrant
Palbociclib in Combination With Fulvestrant Versus Fulvestrant in Advanced Breast Cancer: A Real-world Study in China
The purpose of this study is to evaluate efficacy and safety of CDK4/6 inhibitor Palbociclib in combination with Fulvestrant versus Fulvestrant in female patients with HR+/HER2- advanced breast cancer in a real world setting in…
- Conditions
- Breast Cancer, Fulvestrant, Palbociclib
- Trial name
- NCT04526028
- Testing
- Fulvestrant Injectable Product, Palbociclib
- Where
- China
- Volunteers
- 612 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
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
Malignant Rhabdoid Tumors (MRT), Neuroblastoma
Study of Safety and Efficacy in Patients With Malignant Rhabdoid Tumors (MRT) and Neuroblastoma
LEE011 is a small molecule inhibitor of CDK4/6. LEE011 has demonstrated in vitro and in vivo activity in both tumor models. The primary purpose of this study was to determine the maximum tolerated dose (MTD) and/or recommended…
- Trial name
- NCT01747876
- Testing
- LEE011
- Where
- 13 sites in United States, Australia and 3 more
- Volunteers
- 32 people
- Sponsor
- Novartis Pharmaceuticals
Melanoma
LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma
The primary purpose of the Phase II CLGX818X2102 study is to assess the anti-tumor activity of LGX818 in combination with selected agents.
- Trial name
- LOGIC (NCT01820364)
- Testing
- LGX818
- Where
- 6 sites in United States, Australia and 4 more
- Volunteers
- 15 people
- Sponsor
- Array BioPharma
Locally Advanced or Metastatic Breast Cancer
A Study of Entinostat in Combination With Fulvestrant for the Treatment of Locally Advanced or Metastatic Breast Cancer
This study aims to evaluate the efficacy of Entinostat combined with Fulvestrant in HR+/HER2- advanced breast cancer patients with recurrence/progression after endocrine therapy (primary endpoint: progression-free survival…
- Trial name
- NCT07235618
- Testing
- Entinostat, Fulvestrant
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Sun Yat-sen University
Locally Advanced Metastatic BRAF Mutant Melanoma
Safety and Efficacy of LEE011 and LGX818 in Patients With BRAF Mutant Melanoma.
To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered orally to patients with BRAF mutant melanoma.
- Trial name
- NCT01777776
- Testing
- LEE011, LGX818
- Where
- 9 sites in United States, Australia and 2 more
- Volunteers
- 28 people
- Sponsor
- Array BioPharma
High Grade Glioma, Diffuse Intrinsic Pontine Glioma
A Phase I/II Study of Ribociclib,a CDK4/6 Inhibitor, Following Radiation Therapy
In this research study the investigators want to learn more about the effects, both good and bad, when the study drug Ribociclib is given after radiation therapy.
- Conditions
- High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Bithalamic High Grade Glioma
- Trial name
- NCT02607124
- Testing
- Ribociclib
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Lymphoma, Solid Neoplasm
Ribociclib and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors or Lymphoma
This phase I trial studies the side effects and best dose of ribociclib and gemcitabine hydrochloride in treating patients with solid tumors or lymphoma that have spread to other places in the body and usually cannot be cured or…
- Trial name
- NCT02414724
- Testing
- Gemcitabine Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Roswell Park Cancer Institute
Breast Neoplasm Female
Fulvestrant Versus Fulvestrant Plus Palbociclib in Operable Breast Cancer Responding to Fulvestrant
This is a multicenter, international, double-blind randomized Phase III study to evaluate the pathological complete response (pCR) according to Chevalier classification between Fulvestrant® and the combination of Fulvestrant®…
- Trial name
- SAFIA (NCT03447132)
- Testing
- Fulvestrant 500mg, Palbociclib 125mg, Goserelin 3.6 MG
- Where
- 14 sites in Algeria, Egypt and 6 more
- Volunteers
- 354 people
- Sponsor
- International Cancer Research Group, United Arab Emirates
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in…
- Trial name
- INAVO123 (NCT06790693)
- Testing
- Inavolisib, CDK4/6i, Letrozole
- Where
- 242 sites in United States, Argentina and 18 more
- Volunteers
- 450 people
- Sponsor
- Hoffmann-La Roche
Toxicity, Drug, Progression, Disease
Real-World Clinical Outcomes and Toxicity in Metastatic Breast Cancer Patients Treated With First or Second Line CDK 4/6 Inhibitors and Endocrine Therapy
To assess CDK4/6i toxicity and effect on PFS in the Egyptian population
- Trial name
- NCT06558084
- Testing
- CDK4/6 Inhibitor
- Where
- Egypt
- Volunteers
- 64 people
- Sponsor
- Ain Shams University
ER-Positive Breast Cancer, HER2-negative Breast Cancer
Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer
The study will investigate if CDK4/6 inhibitor holiday will reset the cell cycle process to respond to the combination of fulvestrant and abemaciclib, and this approach may represent an effective therapeutic strategy to manage…
- Trial name
- NCT05305924
- Testing
- Fulvestrant Run-In
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- The Methodist Hospital Research Institute
Breast Cancer, Malignant Neoplasm of Breast
A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer
Palbociclib, the first oral CDK4/6 inhibitor, is an approved medicine indicated for the treatment of a kind of advanced/metastatic breast cancer (MBC), called hormone receptors positive (HR+)/ Human epidermal growth factor…
- Trial name
- NCT06495164
- Testing
- Palbociclib, Aromatase inhibitor, Ribociclib
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Pfizer
Breast Cancer, Brain Metastases
Palbociclib, Trastuzumab,Pyrotinib and Fulvestrant Treatment in Patients With Brain Metastasis From ER/PR Positive, HER-2 Positive Breast Cancer: A Multi-center, Prospective Study in China
The objective of this study is to evaluate the efficacy of combination of palbociclib, trastuzumab and pyrotinib with fulvestrant in ER/PR positive and HER2-positive breast cancer patients with brain metastasis.
- Trial name
- NCT04334330
- Testing
- Palbociclib, Trastuzumab, Pyrotinib and Fulvestrant
- Where
- 2 sites in China
- Volunteers
- 34 people
- Sponsor
- Sun Yat-sen University
Metastatic Solid Tumor, Advanced Cancer
High Definition Medicine for Solid Tumors Oncology
The present study aims to analyze different genetic, phenotypic, environmental, social and lifestyle characteristics of cancer patients who are going to start a first line of cancer treatment with palliative intent and their…
- Trial name
- HDM-PMP22 (NCT06590506)
- Testing
- Wearable
- Where
- 9 sites in Spain
- Volunteers
- 300 people
- Sponsor
- Centro Nacional de Investigaciones Oncologicas CARLOS III
Breast Cancer
CDK4/6 Inhibitor Intensification and Chemotherapy De-Escalation for Early-stage Luminal-HER2 Breast Cancer
The investigators designed a phase III clinical trial involving hormone receptor-positive and HER2-positive stage I breast cancer patients.
- Trial name
- Cinderella (NCT07213206)
- Testing
- CDK 4/6 inhibitor combined therapy (omit chemo), standard of care
- Volunteers
- 1,500 people
- Sponsor
- Fudan University
Metastatic Breast Cancer, ER-positive Breast Cancer
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
This is a Phase 1b open-label, 2-part study in 4 treatment groups. The 4 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).
- Conditions
- Metastatic Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05508906
- Testing
- Palazestrant, Ribociclib, Alpelisib
- Where
- 16 sites in United States, Australia
- Volunteers
- 190 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Breast Cancer
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.
In the phase I part, to determine the recommended doses (RD) and dosing regimens of [177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive…
- Trial name
- NeoB-Cap1 (NCT06247995)
- Testing
- [68Ga]Ga-NeoB, [177Lu]Lu-NeoB, Capecitabine
- Where
- 28 sites in United States, Australia and 11 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals