G1T38, a CDK 4/6 Inhibitor, in Combination With Osimertinib in EGFR-Mutant Non-Small Cell Lung Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 29, 2018 |
| End Date: | April 2023 |
| Contact: | G1 Therapeutics Clinical Contact |
| Email: | clinicalinfo@g1therapeutics.com |
| Phone: | 919-213-9835 |
Phase 1b/2 Safety, Pharmacokinetic, and Efficacy Study of G1T38 in Combination With Osimertinib in Patients With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)
This is 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.
The study is an open-label design, consists of 2 parts: safety, pharmacokinetic, and
dose-finding portion (Part 1), and randomized 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, 144 patients will be enrolled in the study.
combination with osimertinib in patients with EGFR mutation-positive metastatic non-small
cell lung cancer.
The study is an open-label design, consists of 2 parts: safety, pharmacokinetic, and
dose-finding portion (Part 1), and randomized 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, 144 patients will be enrolled in the study.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
2
sites
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