Trials / Completed
CompletedNCT02242045
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Participants With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas (iNHL) or Chronic Lymphocytic Leukemia (CLL)
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Chronic Lymphocytic Leukemia
- Indolent Non-Hodgkin Lymphoma
- Follicular Lymphoma
- Small Lymphocytic Lymphoma
- Lymphoplasmacytic Lymphoma (With or Without Waldenstrom Macroglobulinemia)
- Marginal Zone Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Idelalisib | 150 mg tablet(s) administered orally twice daily |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2014-12-25
- Completion
- 2017-10-17
- First posted
- 2014-09-16
- Last updated
- 2021-03-19
- Results posted
- 2021-03-19
Locations
3 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02242045. Inclusion in this directory is not an endorsement.