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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 is a Phase 1 study that has completed, run by Xcovery Holdings. The registered enrollment target is 131 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01625234
The ClinicalTrials.gov registry entry for NCT01625234 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Xcovery Holdings, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Phase I: X-396 (ensartinib) is the first listed.
NCT01625234 reports 0 study locations.
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.
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