Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC)
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|ClinicalTrials.gov Identifier: NCT02499770|
Recruitment Status : Active, not recruiting
First Posted : July 16, 2015
Last Update Posted : May 25, 2018
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 carboplatin and etoposide in first line treatment for patients with newly diagnosed 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. Approximately, 90 patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part 2 portion.
|Condition or disease||Intervention/treatment||Phase|
|Small Cell Lung Cancer||Drug: Carboplatin Drug: Placebo Drug: Trilaciclib Drug: Etoposide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Etoposide and Carboplatin|
|Actual Study Start Date :||June 26, 2015|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: trilaciclib + carboplatin/etoposide
All patients in part 1 will receive trilaciclib (G1T28) prior to standard chemotherapy- carboplatin and etoposide. Patients will have PK assessments completed on days 1 and 3 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.
Other Name: Paraplatin
Other Name: G1T28
Experimental: trilaciclib/placebo + carboplatin/etoposide
All patients enrolled in part 2 will be randomized to receive either trilaciclib (G1T28) or placebo administered prior to standard chemotherapy- carboplatin and etoposide. 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.
Other Name: Paraplatin
Other Name: G1T28
- 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), Carboplatin and Etoposide [ Time Frame: Days 1 and 3 in Cycle 1 ]Blood samples for the determination of Trilaciclib (G1T28), Carboplatin and Etoposide pharmacokinetics (PK) and its active metabolite(s) will be collected from all patients in Part 1. Blood samples will be collected prior to and after the administration of Trilaciclib (G1T28), Carboplatin and Etoposide on days 1 and 3 cycles 1 only.
- Progression free survival (PFS) [ Time Frame: 24 Months ]
- Overall survival (OS) [ Time Frame: 24 Months ]
- 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): NCT02499770
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|Study Director:||Clinical Contact||G1 Therapeutics, Inc.|