Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Small Cell Lung Cancer
In brief
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28), a Cyclin Dependent Kinase (CDK) 4/6 inhibitor, in preserving the bone marrow and the immune system, in order to decrease chemotherapy-induced myelosuppression and improve anti-tumor efficacy when administered prior to topotecan in patients previously treated for extensive-stage SCLC. The study consisted of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts included 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase began on the day of first dose with study treatment and completes at the Post-Treatment Visit.
Key facts
- Study ID
- NCT02514447
- Run by
- G1 Therapeutics, Inc.
- People needed
- 123
- Starts
- 2015-10-05
- Expected to finish
- 2021-10-04
- Last updated by the study team
- 2025-09-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Genesis Cancer Center — Hot Springs, Arkansas, United States
- Highlands Oncology Group — Rogers, Arkansas, United States
- Compassionate Cancer Care Medical Group, Inc. — Corona, California, United States
- Sutter Medical Group — Sacramento, California, United States
- The Oncology Institute of Hope and Innovation — Whittier, California, United States
- Memorial Hospital - University of Colorado Health — Colorado Springs, Colorado, United States
- Rocky Mountain Cancer Centers — Denver, Colorado, United States
- University of Colorado Health, Oncology Clinical Research Northern Region — Fort Collins, Colorado, United States
- Florida Cancer Specialists - South — Fort Myers, Florida, United States
- Florida Cancer Specialists - North — Tavares, Florida, United States
- University Cancer and Blood Center, LLC — Athens, Georgia, United States
- Emory University — Atlanta, Georgia, United States
- Northside Hospital - Georgia Cancer Specialists — Atlanta, Georgia, United States
- Saint Luke's Cancer Institute — Kansas City, Missouri, United States
- Norris Cotton Cancer Center — Lebanon, New Hampshire, United States
- North Shore Hematology Oncology Associates PC — East Setauket, New York, United States
- Regional Medical Oncology Center — Wilson, North Carolina, United States
- Gabrail Cancer Center — Canton, Ohio, United States
- Oklahoma University - Peggy and Charles Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
- Guthrie Medical Group, PC — Sayre, Pennsylvania, United States
- AnMed Health — Anderson, South Carolina, United States
- Greenville Health System — Greenville, South Carolina, United States
- Gibbs Cancer Center — Spartanburg, South Carolina, United States
- Hanna Cancer Associates - University of Tennessee — Knoxville, Tennessee, United States
- Meharry Medical College — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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