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 : January 27, 2021
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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 |
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Small Cell Lung Cancer | Drug: Trilaciclib Drug: Placebos Drug: Topotecan | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 : | December 2021 |

Arm | Intervention/treatment |
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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 patients 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.
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Drug: Trilaciclib
Other Names:
Drug: Topotecan |
Experimental: Trilaciclib (G1T28) + Topotecan -PART 2
All patients in Part 2 will be randomized 2:1 to receive trilaciclib (G1T28) to be administered prior to standard chemotherapy, topotecan. Patients will have limited PK assessments completed on day 4 in cycle 1 only. All patients 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.
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Drug: Trilaciclib
Other Names:
Drug: Topotecan |
Experimental: Placebo + Topotecan -PART 2
All patients in Part 2 will be randomized 1:2 to receive placebo administered prior to standard chemotherapy, topotecan. Patients will have limited PK assessments completed on day 4 in cycle 1 only. All patients 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.
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Drug: Placebos Drug: Topotecan |
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female subjects aged ≥18 years
- Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry
- Progression during or after prior first- or second-line chemotherapy and eligible to receive topotecan therapy
- At least 1 target lesion that is measurable by RECIST, Version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Adequate organ function
Exclusion Criteria:
- Presence of symptomatic brain metastases requiring immediate treatment with radiation therapy or steroids.
- Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure
- Known history of stroke or cerebrovascular accident within 6 months prior to enrollment
- Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol
- Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment or previous radiotherapy to the target lesion sites (the sites that are to be followed for determination of a response)
- Receipt of any investigational medication within 2 weeks prior to enrollment
- History of topotecan treatment for SCLC

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

Study Director: | Clinical Contact | G1 Therapeutics, Inc. |
Responsible Party: | G1 Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02514447 |
Other Study ID Numbers: |
G1T28-03 2016-004611-13 ( EudraCT Number ) |
First Posted: | August 3, 2015 Key Record Dates |
Last Update Posted: | January 27, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
SCLC |
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Topotecan Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |