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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT02514447
• Date of registration: 31/07/2015
• Prospective Registration: Yes
• Primary sponsor: G1 Therapeutics, Inc.
• Public title: Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy
• Scientific 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
• Date of first enrolment: October 5, 2015
• Target sample size: 120
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02514447
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1/Phase 2

Countries of recruitment

Belgium, Bosnia and Herzegovina, Croatia, Macedonia, The Former Yugoslav Republic of, North Macedonia, Serbia, Slovakia, Slovenia, United States

Contacts

• Name: Clinical Contact
• Affiliation: G1 Therapeutics, Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Small Cell Lung Cancer

Intervention(s)

Drug: Trilaciclib

Drug: Placebos

Drug: Topotecan

Primary Outcome(s)

Treatment related adverse events (AE) [Time Frame: Up to 24 weeks]

Dose Limiting Toxicity [Time Frame: Days 1-21 of Cycle 1]

Secondary Outcome(s)

Hematologic parameters [Time Frame: Up to 20 weeks]

Need for treatment with hematopoietic growth factors [Time Frame: Day 22]

Overall survival (OS) [Time Frame: 24 Month]

Progression free survival (PFS) [Time Frame: 24 Months]

Tumor response based on RECIST, Version 1.1 [Time Frame: Up to 20 weeks]

Pharmacokinetic profile for Trilaciclib (G1T28) and Topotecan [Time Frame: Days 1 and 4 of Cycle 1]

Incidence of chemotherapy dose reductions and dose interruptions overall [Time Frame: Up to 20 weeks]

Need for RBC and platelet transfusions [Time Frame: Up to 20 weeks]

Secondary ID(s)

G1T28-03

2016-004611-13

Source(s) of Monetary Support

Please refer to primary and secondary sponsors