Status:
COMPLETED
G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer
Lead Sponsor:
G1 Therapeutics, Inc.
Conditions:
Carcinoma, Non-Small-Cell Lung
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This was a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with osimertinib in patients with EGFR mutation-positive metastatic non-small cell lung cancer...
Detailed Description
Part 2, the Phase 2 part of the study, was not conducted due to changes in corporate strategy. There were no safety signals identified in Phase 1/Part 1 that would have precluded the conduct of Part 2...
Eligibility Criteria
Inclusion
- Confirmed EGFR mutation for non-small cell lung cancer associated with EGFR TKI sensitivity
- For Part 2, EGFR T790M mutation-positive tumor status
- Left ventricular ejection fraction (LVEF) ≥ institution's lower limit of the reference range
- For Part 1, evaluable or measurable disease as defined by RECIST, Version 1.1
- For Part 2, measurable disease as defined by RECIST, Version 1.1
- ECOG performance status 0 to 1
- Adequate organ function
Exclusion
- Prior treatment with EGFR TKI within 9 days of first study dose
- For Part 1, prior treatment with more than 2 prior lines of chemotherapy for advanced NSCLC
- For Part 2, prior treatment with osimertinib or other T790M active EGFR TKI
- For Part 2, prior chemotherapy for advanced NSCLC
- Active uncontrolled/symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
- Investigational drug within 3 months or 5 half-lives, whichever is longer, of first study dose
- Concurrent radiotherapy, radiotherapy within 28 days of first study dose, previous radiotherapy to the target lesion sites, or prior radiotherapy to \> 25% of bone marrow
- Prior hematopoietic stem cell or bone marrow transplantation
Key Trial Info
Start Date :
March 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03455829
Start Date
March 29 2018
End Date
February 14 2022
Last Update
May 6 2023
Active Locations (8)
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1
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
2
UCLA Medical Center, Division of Hematology/Oncology/Clinical Research Unit
Santa Monica, California, United States, 90404
3
St Joseph Heritage Healthcare
Santa Rosa, California, United States, 95403
4
Sylvester Comprehensive Cancer Center/University of Miami Miller School of Medicine Fox Building, Suite 200 G
Miami, Florida, United States, 33136