At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 304 enrolled
Drug / intervention
LDK378drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Multi-center, Open Label Dose Escalation Study of LDK378, Administered Orally in Adult Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase (ALK)
In Brief
A Phase 1 clinical trial evaluating LDK378 for Tumors Characterized by Genetic Abnormalities of ALK. Completed, enrolled 304 participants across 21 sites in 11 countries.
Detailed Summary
This study assessed the safety and efficacy of LDK378 in adult patients with genetic abnormalities in anaplastic lymphoma kinase (ALK).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Canada, Germany, Italy, Netherlands, Singapore, South Korea, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedJan 2011
Primary CompletionMay 2016
TodayJul 2026
First PostedJan 26, 2011
Enrollment StartJan 24, 2011
Primary CompletionMay 3, 2016
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 15.4 years ago
Interventions
LDK378drug
LDK378 is a selective and a potent inhibitor of anaplastic lymphoma kinase (ALK) activity, is a capsule and is administered orally.