At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 129 enrolled
Drug / intervention
Crizotinibdrug
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.
Phase II, Open Label, Single Arm Study of the Efficacy and Safety of Crizotinib in East Asian Patients With Advanced ALK-Negative NSCLC Harboring a Translocation or Inversion Involving the c-ROS Oncogene (ROS1) Locus
In Brief
A Phase 2 clinical trial evaluating Crizotinib for Non Small Cell Lung Cancer and 2 related conditions. Completed, enrolled 129 participants across 44 sites in 4 countries.
Detailed Summary
To assess treatment effectiveness and safety of oral crizotinib administered to East Asian patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a ROS1 positive gene mutation (translocation or inversion) and confirmed negative for an ALK mutation
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Small Cell Lung Cancer, ROS1 Proto Oncogene, Crizotinib
CountriesChina, Japan, South Korea, Taiwan
CollaboratorsOxOnc Development LP
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 2013
Enrollment StartSep 2013
Primary CompletionJul 2015
Study CompletionJan 2020
TodayJul 2026
First PostedSep 18, 2013
Enrollment StartSep 30, 2013
Primary CompletionJul 31, 2015
Study CompletionJan 22, 2020
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.8 years ago
Interventions
Crizotinibdrug