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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02258607
The ClinicalTrials.gov registry entry for NCT02258607 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sierra Oncology LLC - a GSK company, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Trametinib is the first listed.
NCT02258607 reports 0 study locations.
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.
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