At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 6 enrolled
Drug / intervention
Idelalisibdrug
Likely dose
Idelalisib 150 mgfrom 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 1b Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Subjects With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas or Chronic Lymphocytic Leukemia
In Brief
A Phase 1 clinical trial evaluating Idelalisib for Chronic Lymphocytic Leukemia and 5 related conditions. Completed, enrolled 6 participants across 3 sites.
Detailed Summary
The primary objective of this study is to evaluate the 28-day safety and tolerability, and to determine the pharmacokinetics (PK) of idelalisib in Japanese participants with relapsed or refractory indolent B-cell non-Hodgkin lymphomas (iNHL) or chronic lymphocytic leukemia (CLL).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia, Indolent Non-Hodgkin Lymphoma, Follicular Lymphoma, Small Lymphocytic Lymphoma, Lymphoplasmacytic Lymphoma (With or Without Waldenstrom Macroglobulinemia), Marginal Zone Lymphoma
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 2014
Enrollment StartOct 2014
Primary CompletionDec 2014
Study CompletionOct 2017
TodayJul 2026
First PostedSep 16, 2014
Enrollment StartOct 1, 2014
Primary CompletionDec 25, 2014
Study CompletionOct 17, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.8 years ago
Interventions
Idelalisibdrug
150 mg tablet(s) administered orally twice daily