Palbociclib clinical trials, in English

This research study is studying This research study is studying the how well it works and safety of the following study drugs as a possible treatment for recurrent central nervous system (CNS) metastases: * Palbociclib alone (Cohort 1) * The combination of palbociclib and pembrolizumab (Cohort 2) Pfizer and Merck, pharmaceutical companies, are supporting this research study by providing the study drugs as well as funding for research activities.

NCT02896335 · Official ClinicalTrials.gov record · Massachusetts General Hospital

This is an umbrella study evaluating the how well it works and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages.

NCT03424005 · Official ClinicalTrials.gov record · Hoffmann-La Roche

This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inhibitor palbociclib.

NCT03454035 · Official ClinicalTrials.gov record · UNC Lineberger Comprehensive Cancer Center

This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical how well it works of PF-07248144 as a single agent and in combination with other agents

NCT04606446 · Official ClinicalTrials.gov record · Pfizer

This is a multi-center biomarkers study aiming to prospectively collect biological samples from patients with ER+ and HER2-negative metastatic breast cancer, who are candidate to first-line treatment with an aromatase inhibitor and a CDK4/6 inhibitor as per standard clinical practice. Blood and tissue samples will be collected for biomarker analysis, including thymidine kinase1 activity, gene expression signatures and circulating tumor DNA.

NCT04660435 · Official ClinicalTrials.gov record · Fondazione Sandro Pitigliani

This phase Ib trial is to find out the best dose, possible benefits and/or side effects of talazoparib when given in combination with palbociclib, axitinib, or crizotinib in treating patients with solid tumors that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). PARPs are proteins that help repair damaged DNA, the genetic material that serves as the body's instruction book.

NCT04693468 · Official ClinicalTrials.gov record · M.D. Anderson Cancer Center

This is a Phase Ib/II, open-label, multicenter, randomly assigned umbrella study in participants with breast cancer. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population.

NCT04802759 · Official ClinicalTrials.gov record · Hoffmann-La Roche

This multicenter, open-label, randomly assigned phase 3 trial will determine if palbociclib and cetuximab (Arm 1) improves overall survival (OS) in comparison to cetuximab this drug alone (Arm 2) in patients with CDKN2A-altered, HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on a PD-1/L1 inhibitor (given as this drug alone or in combination with other therapy).

NCT04966481 · Official ClinicalTrials.gov record · Washington University School of Medicine

This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials.

NCT05564377 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

Background: Kidney cancer is the 12th leading cause of cancer-related death in the United States. Some kidney tumors do not respond well to current treatments.

NCT05665361 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

The goal of this clinical trial is to assess the how well it works, whether it is safe and how hard side effects are to live with of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the how well it works of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.

NCT05696626 · Official ClinicalTrials.gov record · LeonaBio

Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid tumors with P13Ka mutations. Part 1 will evaluate STX-478 as this drug alone in participants with advanced solid tumors.

NCT05768139 · Official ClinicalTrials.gov record · Eli Lilly and Company

This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors. AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK 2).

NCT05867251 · Official ClinicalTrials.gov record · Avenzo Therapeutics, Inc.

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.

NCT06062498 · Official ClinicalTrials.gov record · Northwestern University

This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors.

NCT06126276 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)

This study wants to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with Metastatic Breast Cancer (MBC) (age ≥ 60 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs. The primary objective of the CDK Study is to compare time to treatment discontinuation (TTD) on the approved dosing for palbociclib (125 mg orally daily on days 1-21 of 28-day cycle) or ribociclib (600 mg orally daily on days 1-21 of 28-day cycle) vs.

NCT06377852 · Official ClinicalTrials.gov record · American Society of Clinical Oncology

The primary objective of the study is to measure how well it works of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer

NCT06380751 · Official ClinicalTrials.gov record · AstraZeneca

This is a Phase 3, open-label, randomly assigned, clinical trial evaluating the how well it works and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.

NCT06757634 · Official ClinicalTrials.gov record · Celcuity Inc

This study wants to find out whether mirdametinib in combination with palbociclib is an effective and safe treatment for people with metastatic, recurrent, and unresectable liposarcoma. This study will test different doses of mirdametinib in combination with a fixed dose of palbociclib to find the best safe dose for further testing.

NCT06843967 · Official ClinicalTrials.gov record · Memorial Sloan Kettering Cancer Center

Medulloblastoma (MB), a rare yet critical pediatric brain tumor, is divided into 4 molecular subgroups (WNT, SHH, Group 3, Group 4), each with distinct genetic profiles. Despite diagnostic and therapeutic advances, neurotoxicity from standard treatments (resection, radiotherapy, chemotherapy) and the need for long-term care remain challenges.

NCT06959979 · Official ClinicalTrials.gov record · Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This study wants to assess BMS-986500 as this drug alone in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.

NCT06997029 · Official ClinicalTrials.gov record · Bristol-Myers Squibb

The goal of this research study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment of participants with advanced clear cell renal cell carcinoma (ccRCC) or translocation renal cell carcinoma (tRCC). The name of the study drugs involved in this research study is: * Sasanlimab (a type of monoclonal antibody) * Palbociclib (a type of kinase inhibitor) * Axitinib (a type of Vascular endothelial growth factor inhibitor)

NCT07123090 · Official ClinicalTrials.gov record · Stephanie Berg

The purpose of the study is to assess the how well it works and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.

NCT07174336 · Official ClinicalTrials.gov record · Eli Lilly and Company

The main purpose of this study is to measure the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA/mBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.

NCT07347600 · Official ClinicalTrials.gov record · Hoffmann-La Roche

This is a prospective validation study, multicenter, open-label, single-arm study, evaluating the concordance between capillary microsampling (using the VAMS Mitra device) and venous sampling in patients undergoing CDK4/6 therapy.

NCT07491380 · Official ClinicalTrials.gov record · Institut Curie

This study wants to investigate the how well it works and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.

NCT07492641 · Official ClinicalTrials.gov record · BeOne Medicines

The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary how well it works of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.

NCT07558733 · Official ClinicalTrials.gov record · Faeth Therapeutics

This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to retreat with T-DXd once patients progress under maintenance aimed to maximizing disease control, optimizing tolerability, and preserving T-DXd as a future therapeutic option, while ensuring participant safety and regulatory compliance in participants with HER2+/HR+ advanced/metastatic breast cancer.

NCT07683754 · Official ClinicalTrials.gov record · Daiichi Sankyo

This study will measure the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes.

NCT07748208 · Official ClinicalTrials.gov record · Hoffmann-La Roche