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 ■
