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NCT02258607 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Sierra Oncology LLC - a GSK company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT02258607: Clinical Trial Phase 1 study, sponsored by Sierra Oncology LLC - a GSK company.
NCT02258607 is a Phase 1 study that was terminated before completion, run by Sierra Oncology LLC - a GSK company. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02258607, a Phase 1 study, was terminated before completion, sponsored by Sierra Oncology LLC - a GSK company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Dose limiting toxicities (DLTs) refer to toxicities experienced during the first 28 days of treatment that have been judged to be clinically significant and at least possibly related to study treatment.
Interventions
- DRUG Trametinib
- DRUG Momelotinib (MMB)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2015-03-11 |
| Est. Completion | 2017-02-27 |
| Phase | Phase 1 |
Why NCT02258607 stopped before completion
NCT02258607 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Trametinib is the first listed.
NCT02258607 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02258607 about?
NCT02258607 is a clinical study titled "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". 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-...
What is the current status of trial NCT02258607?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2015-03-11. Estimated completion is 2017-02-27.
What interventions are being tested in trial NCT02258607?
The interventions under investigation include: Trametinib (DRUG), Momelotinib (MMB) (DRUG).
Who is sponsoring clinical trial NCT02258607?
This trial is sponsored by Sierra Oncology LLC - a GSK company, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02258607's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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