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P1-19-17 : Dose escalation and expansion study of lerociclib (G1T38), an oral CDK4/6 inhibitor, dosed with no drug holiday in combination with fulvestrant in patients with HR+/HER2- advanced breast cancer

Researchers

Presenter

  • Iurie Bulat

Principal Investigators

  • Marina Maglakelidze

  • Carmen Murias

  • Boris Krastev

  • Richard D Baird

  • Andrew M Wardley

  • Rebecca Roylance

  • Adrian Crijanovschi

  • Maia Gogiladze

  • Yili Pritchett

  • Amy McCullough

  • Chao Li

  • Jessica A Sorrentino

  • Rajesh Malik

  • Andrew P Beelen

Medical Centers

  • ARENSIA Exploratory Medicine, Institute of Oncology, Chisinau, Moldova, Republic of

  • LLC ARENSIA Exploratory Medicine, Tblisi, Georgia

  • Sarah Cannon Research Institute, London, United Kingdom

  • MHAT for Women’s Health, Nadezhda, Sofia, Bulgaria

  • Cancer Research UK, Cambridge Research Institute, Cambridge, United Kingdom

  • The NIHR Manchester Clinical Research Facility at The Christie NHS Foundation Trust and Division of Cancer Sciences, School of Medical Sciences, Faculty of Biology, Manchester, United Kingdom

  • NIHR University College London Hospitals Biomedical Research Centre, London, United Kingdom

  • ARENSIA Exploratory Medicine, Institute of Oncology, Chisinau, Moldova, Republic of

  • LLC ARENSIA Exploratory Medicine, Tblisi, Georgia

  • G1 Therapeutics, Inc, Research Triangle Park, NC

Locations

  • Republic of South Korea

  • Georgia

  • United Kingdom

  • Bulgaria

  • United States

Companies

  • N/A

Study Components

Therapeutic Area

  • Blood/haematological Diseases

Disease

  • Drug-induced liver injury

  • Venous thrombosis

  • Thrombocytopenia

  • Breast cancer

  • Neutropenia

  • Solid malignancies

  • Anemia

Biomarkers

  • Cyclin-dependent kinase 4

  • erb-b2 receptor tyrosine kinase 2

Drug/Treatment

  • Fulvestrant

Outcome

  • N/A

Study Design

  • Randomized

  • Pharmacokinetics

  • Pharmacodynamics

  • Expansion Study

  • Dose Escalation

Phase

  • II

Study Id's

  • NCT02983071

Sponsors

  • N/A

Result

  • N/A

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