Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer
Public ClinicalTrials.gov record NCT01625234. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 1/2, First-in-Human, Dose-Escalation Study of X-396 (Ensartinib) in Patients With Advanced Solid Tumors and Expansion Phase in Patients With ALK-positive Non-Small Cell Lung Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01625234
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 131 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2012
- Primary completion
- Sep 16, 2020
- Completion
- Sep 16, 2020
- Last update posted
- Apr 29, 2026
2012 – 2020
United States locations
- U.S. sites
- 14
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Med Ctr | Duarte | California | 91010 | — |
| UCSD Moores Cancer Center | La Jolla | California | 92093 | — |
| University of Southern California Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Stanford University | Stanford | California | 94305 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| New York University Langone Medical Center | New York | New York | 10016 | — |
| Providence Portland Medical Center | Portland | Oregon | 97213 | — |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | — |
| Vanderbilt University | Nashville | Tennessee | 37240 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Wisconsin Carbone Cancer Ctr | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01625234, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 29, 2026 · Synced Sep 10, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01625234 live on ClinicalTrials.gov.