Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy
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|ClinicalTrials.gov Identifier: NCT02514447|
Recruitment Status : Active, not recruiting
First Posted : August 3, 2015
Last Update Posted : June 14, 2019
This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to topotecan in patients previously treated for extensive-stage SCLC.
The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. The open-label portion enrolled 32 patients and the randomized portion will enroll approximately 90 patients.
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer||Drug: Trilaciclib Drug: Placebos Drug: Topotecan||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Previously Treated Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Topotecan Chemotherapy|
|Actual Study Start Date :||October 5, 2015|
|Actual Primary Completion Date :||September 28, 2018|
|Estimated Study Completion Date :||January 2020|
Experimental: Trilaciclib (G1T28) + Topotecan
All patients in Part 1 will receive trilaciclib (G1T28) prior to standard chemotherapy, topotecan. Patients will have PK assessment completed on days 1 and 4 in cycle 1 only. All patents will be monitored for safety and tumor response based on RECIST version 1.1. Safety surveillance reporting of AEs and concomitant medications commences at the time that informed consent is obtained and continues through the Post Treatment Visit.
Experimental: Trilaciclib (G1T28)/Placebo + Topotecan
All patients in Part 2 will be randomized 2:1 to receive either trilaciclib (G1T28) or placebo administered prior to standard chemotherapy, topotecan. Patients will have limited PK assessments completed on day 4 in cycle 1 only. All patents will be monitored for safety and tumor response based on RECIST version 1.1. Safety surveillance reporting of AEs and concomitant medications commences at the time that informed consent is obtained and continues through the Post Treatment Visit.
- Dose Limiting Toxicity [ Time Frame: Days 1-21 of Cycle 1 ]
- Treatment related adverse events (AE) [ Time Frame: Up to 24 weeks ]
- Pharmacokinetic profile for Trilaciclib (G1T28) and Topotecan [ Time Frame: Days 1 and 4 of Cycle 1 ]Blood samples for the determination of trilaciclib (G1T28) and topotecan
- Progression free survival (PFS) [ Time Frame: 24 Months ]
- Overall survival (OS) [ Time Frame: 24 Month ]
- Hematologic parameters [ Time Frame: Up to 20 weeks ]The following will be assessed: hemoglobin, hematocrit, white blood cells with differential and platelet counts
- Tumor response based on RECIST, Version 1.1 [ Time Frame: Up to 20 weeks ]
- Need for RBC and platelet transfusions [ Time Frame: Up to 20 weeks ]
- Need for treatment with hematopoietic growth factors [ Time Frame: Day 22 ]
- Incidence of chemotherapy dose reductions and dose interruptions overall [ Time Frame: Up to 20 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514447
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|Study Director:||Clinical Contact||G1 Therapeutics, Inc.|