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)
Stopped early · Phase 1
Conditions studied: EGFR Mutated EGFR TKI Naive Metastatic NSCLC
In brief
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.
Key facts
- Study ID
- NCT02206763
- Run by
- Sierra Oncology LLC - a GSK company
- People needed
- 11
- Starts
- 2014-10-16
- Expected to finish
- 2017-02-16
- Last updated by the study team
- 2019-02-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Study site — Duarte, California, United States
- Study site — Palo Alto, California, United States
- Study site — Whittier, California, United States
Full record on ClinicalTrials.gov
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