Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naive Metastatic Non-Small Cell Lung Cancer (NSCLC)
Summary
This study will evaluate the safety, preliminary efficacy, and pharmacokinetics (PK) of momelotinib (MMB) and erlotinib, as well as define the maximum tolerated dose (MTD) of momelotinib (MMB) combined with erlotinib in adults with epidermal growth factor receptor (EGFR)-mutated, EGFR tyrosine kinase inhibitor (TKI) naive metastatic non-small cell lung cancer (NSCLC). Participants will be sequentially enrolled to receive progressively increasing doses of momelotinib (MMB) in combination with erlotinib. Escalation of momelotinib (MMB) doses will proceed to the MTD, defined as the highest tested dose associated with dose-limiting toxicities (DLT) during the first 28 days of combined erlotinib and momelotinib (MMB) treatment. There will be four dose levels and each treatment cycle will consist of 28 days.
Timeline
- Start
- 2014-10-16
- Primary completion
- 2017-01-12
- Completion
- 2017-02-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | 50 mg | Oral |
| Subject | Erlotinib | Small molecule | 75 mg | Oral |
| Subject | Erlotinib | Small molecule | 100 mg | Oral |
| Subject | Erlotinib | Small molecule | 150 mg | Oral |
| Subject | Momelotinib | Small molecule | 100 mg | Oral |
| Subject | Momelotinib | Small molecule | 200 mg | Oral |
Indications
No indication recorded.