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NCT02503358 · ClinicalTrials.gov registry record · Phase 1
Selumetinib and Paclitaxel as Second-Line Treatment in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer
A Phase 1 study of Stage IV Non-Small Cell Lung Cancer AJCC v7 and Stage IIIB Non-Small Cell Lung Cancer AJCC v7, sponsored by OHSU Knight Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT02503358: Completed Phase 1 study of Stage IV Non-Small Cell Lung Cancer AJCC v7 and Stage IIIB Non-Small Cell Lung Cancer AJCC v7, sponsored by OHSU Knight Cancer Institute.
NCT02503358 is a Phase 1 study of Stage IV Non-Small Cell Lung Cancer AJCC v7 and Stage IIIB Non-Small Cell Lung Cancer AJCC v7 that has completed, run by OHSU Knight Cancer Institute. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02503358, a Phase 1 study of Stage IV Non-Small Cell Lung Cancer AJCC v7 and Stage IIIB Non-Small Cell Lung Cancer AJCC v7, has completed, sponsored by OHSU Knight Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized phase I trial is studying the side effects and the best dose of selumetinib when given together with paclitaxel as a second line therapy in treating patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Selumetinib may stop or slow the growth of tumor cells by blocking a protein called mitogen-activated protein kinase (MEK) that is needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving selumetinib together with paclitaxel may kill more tumor cells.
Primary Outcome
Treatment arms will be summarized reporting the number of patients treated; the number who experience grade 3 or higher treatment-related AE. In addition, number of treatment cycles received will be summarized using descriptive statistics (median and range) by treatment arm. Comprehensive safety data on all toxicities will be tabulated by type, grade, duration, attribution to treatment, and treatment arm. A patient level summary by worst grade toxicity will be included. Laboratory data and conco
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- DRUG Selumetinib
- OTHER Pharmacological Study
Study Locations (1)
Oregon
- OHSU Knight Cancer Institute - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2016-07-21 |
| Est. Completion | 2020-07-16 |
| Phase | Phase 1 |
What the finished NCT02503358 record still lists
NCT02503358 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 2 conditions, with Stage IV Non-Small Cell Lung Cancer AJCC v7 appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02503358 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT02503358 about?
NCT02503358 is a clinical study titled "Selumetinib and Paclitaxel as Second-Line Treatment in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer". This randomized phase I trial is studying the side effects and the best dose of selumetinib when given together with paclitaxel as a second line therapy in treating patients with stage IIIB-IV non-small cell lung cancer (NSCLC). Selumetinib may stop or slow the growth of tumor cells by blocking a pr...
What is the current status of trial NCT02503358?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2016-07-21. Estimated completion is 2020-07-16.
What conditions does trial NCT02503358 study?
This clinical trial studies the following conditions: Stage IV Non-Small Cell Lung Cancer AJCC v7, Stage IIIB Non-Small Cell Lung Cancer AJCC v7.
What interventions are being tested in trial NCT02503358?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Selumetinib (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT02503358?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02503358 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02503358's enrollment target sits among peer trials
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