Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: G1 Therapeutics, Inc.
• Treatments: Topotecan

Criteria

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