LDK378 in Adult Patients With ALK-activated NSCLC Previously Treated With Chemotherapy and Crizotinib
Public ClinicalTrials.gov record NCT01685060. 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
A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Adult Patients With ALK-activated Non-small Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A single-arm, open-label, multicenter, phase II study. Treatment with LDK378 750 mg qd continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anti-cancer therapy and/or died. LDK378 could be continued beyond RECIST-defined progressive disease (PD) as assessed by the investigator if, in the judgment of the investigator, there was evidence of clinical benefit. In these patients tumor assessment would continue as per the schedule of assessments until treatment with LDK378 was permanently discontinued. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator
Study identification
- NCT ID
- NCT01685060
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 140 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
- Nov 26, 2012 (Actual)
- Primary completion
- Mar 29, 2016 (Actual)
- Completion
- Mar 29, 2016 (Actual)
- Last update posted
- Jun 19, 2017
2012 – 2016
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Highlands Oncology Group Dept of Highlands Oncology Grp | Fayetteville | Arkansas | 72703 | — |
| City of Hope National Medical Center Dept of Oncology 2 | Duarte | California | 91010-3000 | — |
| University of California at Los Angeles Reg-5 | Los Angeles | California | 90095 | — |
| University of California at San Diego, Moores Cancer Ctr SC | San Diego | California | 92103 | — |
| Stanford University Medical Center Stanford Cancer Center(2) | Stanford | California | 94304 | — |
| University of Colorado Hospital SC | Aurora | Colorado | 80045 | — |
| Emory University School of Medicine/Winship Cancer Institute Dept of Oncology | Atlanta | Georgia | 30322 | — |
| University of Chicago Medical Center SC | Chicago | Illinois | 60637 | — |
| University of Kansas Cancer Center DeptofUofKansas CancerCenter-2 | Kansas City | Kansas | 66160 | — |
| Cancer Center of Kansas Dept of CCK | Wichita | Kansas | 67214-3728 | — |
| Maryland Oncology Hematology, P.A. SC | Rockville | Maryland | 20850 | — |
| Massachusetts General Hospital Mass General | Boston | Massachusetts | 02114 | — |
| Levine Cancer Institute SC 1 | Charlotte | North Carolina | 28203 | — |
| Sarah Cannon Research Institute Drug Ship - 4 | Nashville | Tennessee | 37203 | — |
| U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office | Dallas | Texas | 75390 | — |
| Seattle Cancer Care Alliance SC-1 | Seattle | Washington | 98105 | — |
| University of Wisconsin Univ Wisc 2 | 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 35 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01685060, 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 Jun 19, 2017 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01685060 live on ClinicalTrials.gov.