Efficacy and Safety of Momelotinib Combined With Trametinib in Adults With Metastatic KRAS-mutated Non-Small Cell Lung Cancer (NSCLC) Who Have Failed Platinum-Based Chemotherapy Preceded by a Dose-finding Lead-in Phase
Stopped early · Phase 1
Conditions studied: Relapsed Metastatic KRAS-Mutated Non-Small Cell Lung Cancer
In brief
This study is conducted in two phases. The Dose-finding Lead-in Phase, Part A, will evaluate the safety and determine the maximum tolerated dose (MTD) of momelotinib (MMB) when combined with trametinib. Once the MTD of momelotinib (MMB) is determined, the study will proceed to the Dose-finding Lead-in Phase, Part B, to determine the MTD of trametinib. After the MTD is established, the study may proceed to an expansion phase to determine the efficacy, safety, and tolerability of MMB combined with trametinib at the MTD in participants with kirsten rat sarcoma viral oncogene homolog (KRAS) mutated metastatic non-small cell lung cancer (NSCLC). Each treatment cycle will consist of 28 days and treatment will continue in the absence of disease progression, unacceptable toxicity, consent withdrawal, or participant's refusal of treatment.
Key facts
- Study ID
- NCT02258607
- Run by
- Sierra Oncology LLC - a GSK company
- People needed
- 21
- Starts
- 2015-03-11
- Expected to finish
- 2017-02-27
- 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 — Sacramento, California, United States
- Study site — Boston, Massachusetts, United States
- Study site — Fairfax, Virginia, United States
- Study site — Spokane, Washington, United States
Full record on ClinicalTrials.gov
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