Selected Clinical Trials of CDK4/6 Inhibitors


This Clinical Trials Resource Guide includes a selection of actively recruiting clinical trials of cyclin-dependent kinase 4/6 (CDK4/6) inhibitors, including palbociclib, ribociclib, and abemaciclib in multiple tumor types. All of the studies here and many others are listed on the National Institutes of Health website at ClinicalTrials.gov.

PHASE I

Study Title: An Open-Label phase Ib Study of Palbociclib Plus Abraxane (Nab-paclitaxel) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

Study Type: Phase I/interventional

Study Sponsor and Collaborators: Pfizer, Celgene

Purpose: To study the effects of multiple-dose, dose-escalation, safety, pharmacokinetic, and pharmacodynamic elements of palbociclib in combination with nab-paclitaxel in sequential cohorts of adult patients with metastatic pancreatic ductal adenocarcinoma, with maximum tolerated dose expansion cohort(s)

Primary Outcome Measures: Number of participants with dose-limiting toxicities [time frame: baseline up to 28 days]

Contact: Pfizer CT.gov Call Center; (800) 718-1021

ClinicalTrials.gov Identifier: NCT02501902


***

Study Title: Abemaciclib in Children With Diffuse Intrinsic Pontine Glioma or Recurrent/Refractory Solid Tumors

Study Type: Phase I/interventional

Study Sponsor: Emory University

Purpose: This is a phase I clinical trial evaluating abemaciclib, an inhibitor of cyclin-dependent kinases 4 and 6 in children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) (stratum A) and in relapsed/refractory/progressive malignant brain tumor (grade III/IV) and solid tumor patients (stratum B).

Primary Outcome Measures: Maximum tolerated dose for diffuse intrinsic pontine glioma (time frame: week 6)

Contact: Jaclyn Smith, MBA, Children’s Healthcare of Atlanta; 404-785-0692, jaclyn.smith@choa.org

Clinical Trials Identifier: NCT02644460

***

Study Title: Early-Phase Study to Assess Tumor Pharmacokinetics and Efficacy of the CDK4/6 Inhibitor Ribociclib (LEE011) in Patients With Recurrent Glioblastoma or Anaplastic Glioma

Study Type: Phase I/interventional/single-group assignment

Study Sponsor and Collaborators: University of Virginia, Novartis Pharmaceuticals

Purpose: To assess the ability of ribociclib (LEE011) to inhibit CDK4/CDK6/Rb/E2F signaling and cell proliferation/viability in core and infiltrating tumor tissues obtained from patients with recurrent glioblastoma or anaplastic glioma compared with the baseline/primary pathologic tumor specimen

Primary Outcome Measures: Inhibition of CDK4/CDK6 signaling pathway in cell proliferation [time frame: an expected average of 1 year (to allow laboratory quality assessment of tumor proliferation)]

Contact: Johanna J. Loomba, University of Virginia; (434) 924-5859, jjl4d@virginia.edu

ClinicalTrials.gov Identifier: NCT02345824


PHASE I/II

Study Title: A Phase I/II Study of Ribociclib, a CDK4/6 Inhibitor, Following Radiation Therapy in Children With Newly Diagnosed Nonbiopsied Diffuse Pontine Gliomas (DIPG) and RB+ Biopsied DIPG and High-Grade Gliomas

Study Type: Phase I/II/interventional/parallel assignment

Study Sponsor and Collaborators: Children’s Hospital Medical Center Cincinnati, Novartis

Purpose: To study the effects of ribociclib in newly diagnosed high-grade glioma screened for the Rb1 protein in patients who have recently finished radiation therapy

Primary Outcome Measures: Number of adverse events [time frame: 6 months], number of patients alive at 1 year [time frame: 1 year]

Contact: Laura Fossett, Children’s Hospital Medical Center Cincinnati, (513) 636-2799

ClinicalTrials.gov Identifier: NCT02607124

PHASE II

Study Title: A Phase II Study of Abemaciclib in Recurrent Glioblastoma

Study Type: Phase II/interventional/crossover assignment

Study Sponsor and Collaborators: Dana-Farber Cancer Institute, Eli Lilly and Company

Purpose: To study the targeted therapy abemaciclib as a possible treatment for recurrent glioblastoma

Primary Outcome Measures: Intratumoral abemaciclib concentration [time frame: 2 years]; 6-month progression-free survival [time frame: 6 months]

Contact: Eudocia Q. Lee, MD, MPH, Dana-Farber Cancer Institute; (617) 632-2166, eqlee@partners.org

ClinicalTrials.gov Identifier: NCT02981940

***

Study Title: A Phase II Study of Palbociclib in Progressive Brain Metastases Harboring Alterations in the CDK Pathway

Study Type: Phase II/interventional/single-group assignment

Study Sponsor and Collaborators: Massachusetts General Hospital, Pfizer

Purpose: To study palbociclib as a possible treatment for recurrent brain metastases

Primary Outcome Measures: Clinical benefit rate (intracranial) [time frame: 8 weeks]

Contact: Priscilla Brastianos, MD, Massachusetts General Hospital; (617) 643-1939

ClinicalTrials.gov Identifier: NCT02896335

***

Study Title: Phase II Study of Abemaciclib (LY2835219) in Dedifferentiated Liposarcoma

Study Type: Phase II/interventional/single-group assignment

Study Sponsor and Collaborators: Memorial Sloan Kettering Cancer Center, Eli Lilly and Company

Purpose: To learn whether abemaciclib will increase progression-free survival or cause a partial or complete response in dedifferentiated liposarcoma

Primary Outcome Measures: Progression-free disease [time frame: 12 weeks]

Contact: Mark Dickson, MD, Memorial Sloan Kettering Cancer Center; (646) 888-4164

ClinicalTrials.gov Identifier: NCT02846987

***

Study Title: Phase II Trial of Palbociclib (PD-0332991) in Patients With Metastatic Urothelial Cancer After Failure of First-Line Chemotherapy

Study Type: Phase II/interventional/single-group assignment

Study Sponsor and Collaborators: University of North Carolina (UNC) Lineberger Comprehensive Cancer Center

Purpose: To evaluate palbociclib (PD-0332991) in patients with metastatic urothelial carcinoma with cyclin-dependent kinase inhibitor 2A (CDKN2A; also referred to as p16) loss and positive retinoblastoma expression after failure of first-line chemotherapy

Primary Outcome Measures: Progression-free survival [time frame: 4 months]

Contact: Maureen Tynan, RN, UNC; (919) 843-7039, maureen_tynan@med.unc.edu

ClinicalTrials.gov Identifier: NCT02334527

***

Study Title: A Study of Abemaciclib Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma

Study Sponsor and Collaborators: Eli Lilly and Company

Purpose: To evaluate the safety and efficacy of abemaciclib alone and in combination with other drugs vs standard of care in participants with previously treated metastatic pancreatic ductal adenocarcinoma.

Primary Outcome Measures: Stage 1: Disease Control Rate: Percentage of Participants with a Best Overall Response of Complete Response, Partial Response, or Stable Disease [Time Frame: Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (~ 17 months)]

Contact: There may be multiple sites in this clinical trial. 108777-CTLILLY (1-877-285-4559 or 1-317-615-4559)

ClinicalTrials.gov Identifier: NCT02981342

***

Study Title: A Phase II Trial of Ribociclib (LEE011) and Letrozole in Estrogen Receptor–Positive Relapsed Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinomas, and Endometrial Cancers

Study Type: Phase II/interventional/single-group assignment

Study Sponsor and Collaborators: Mayo Clinic, National Cancer Institute

Purpose: To study how well ribociclib and letrozole work in treating patients with relapsed estrogen receptor–positive ovarian, fallopian tube, primary peritoneal, or endometrial cancer

Primary Outcome Measures: Proportion of patients alive and progression-free at 12 weeks [time frame: at 12 weeks]

Contact: Multiple study locations

ClinicalTrials.gov Identifier: NCT02657928 ■




By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.