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NCT02535325 · ClinicalTrials.gov registry record · Phase 1
Methoxyamine Hydrochloride, Pemetrexed Disodium, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIIA-IV Non-small Cell Lung Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT02535325: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT02535325 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02535325, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of methoxyamine when given together with pemetrexed disodium, cisplatin, and radiation therapy in treating patients with stage IIIA-IV non-small cell lung cancer. Drugs used in chemotherapy, such as methoxyamine hydrochloride, pemetrexed disodium, and cisplatin, 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. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving methoxyamine hydrochloride together with pemetrexed disodium, cisplatin, and radiation therapy may kill more tumor cells.
Primary Outcome
Will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. MTD is defined as the highest dose level in which 0/6 or 1/6 patients suffer dose-limiting toxicity.
Interventions
- DRUG Cisplatin
- RADIATION Intensity-Modulated Radiation Therapy
- RADIATION 3-Dimensional Conformal Radiation Therapy
- DRUG Methoxyamine
- DRUG Methoxyamine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2015-09-30 |
| Est. Completion | 2022-06-14 |
| Phase | Phase 1 |
What the finished NCT02535325 record still lists
NCT02535325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 5 interventions - of which Cisplatin is the first listed.
NCT02535325 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02535325 about?
NCT02535325 is a clinical study titled "Methoxyamine Hydrochloride, Pemetrexed Disodium, Cisplatin, and Radiation Therapy in Treating Patients With Stage IIIA-IV Non-small Cell Lung Cancer". This phase I trial studies the side effects and best dose of methoxyamine when given together with pemetrexed disodium, cisplatin, and radiation therapy in treating patients with stage IIIA-IV non-small cell lung cancer. Drugs used in chemotherapy, such as methoxyamine hydrochloride, pemetrexed diso...
What is the current status of trial NCT02535325?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2015-09-30. Estimated completion is 2022-06-14.
What interventions are being tested in trial NCT02535325?
The interventions under investigation include: Cisplatin (DRUG), Intensity-Modulated Radiation Therapy (RADIATION), 3-Dimensional Conformal Radiation Therapy (RADIATION), Methoxyamine (DRUG), Methoxyamine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT02535325?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02535325's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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