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NCT01625234 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer
A Phase 1 study, sponsored by Xcovery Holdings.
- Completed
- Registry status
- Phase 1
- Development phase
- 131
- Enrollment target
NCT01625234: Completed Phase 1 study, sponsored by Xcovery Holdings.
NCT01625234 is a Phase 1 study that has completed, run by Xcovery Holdings. The registered enrollment target is 131 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (118% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01625234, a Phase 1 study, has completed, sponsored by Xcovery Holdings.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 131 participants
- Enrollment target
Study Summary
This is the first human study to use X-396 (ensartinib), a drug being developed for treatment of advanced cancers. The initial purpose of the study is to determine the largest amount of X-396 that can be safely given to humans (the maximum tolerated dose). Once the recommended Phase 2 dose has been determined, an expansion phase will assess the preliminary anti-tumor activity of X-396 in ALK-positive non-small cell lung cancer. The study will also provide early information on how the body handles the drug (pharmacokinetics) and on the efficacy of X-396.
Primary Outcome
To evaluate the safety/tolerability of X-396 (ensartinib) and determine the maximum tolerated dose (MTD) of X-396 as a single agent.
Interventions
- DRUG Phase I: X-396 (ensartinib)
- DRUG Phase II: X-396 (ensartinib)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2012-06 |
| Est. Completion | 2020-09-17 |
| Phase | Phase 1 |
What the finished NCT01625234 record still lists
NCT01625234 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (118% higher).
The record links to 0 conditions, and to 2 interventions - of which Phase I: X-396 (ensartinib) is the first listed.
NCT01625234 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01625234 about?
NCT01625234 is a clinical study titled "Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer". This is the first human study to use X-396 (ensartinib), a drug being developed for treatment of advanced cancers. The initial purpose of the study is to determine the largest amount of X-396 that can be safely given to humans (the maximum tolerated dose). Once the recommended Phase 2 dose has been ...
What is the current status of trial NCT01625234?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 131 participants. The study started on 2012-06. Estimated completion is 2020-09-17.
What interventions are being tested in trial NCT01625234?
The interventions under investigation include: Phase I: X-396 (ensartinib) (DRUG), Phase II: X-396 (ensartinib) (DRUG).
Who is sponsoring clinical trial NCT01625234?
This trial is sponsored by Xcovery Holdings, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01625234's enrollment target sits among peer trials
131 439th of 2000 higher than 1,562 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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