A Extension Study of Idelalisib for Patients With Chronic Lymphocytic Leukemia Who Participated in GS-US-312-0116
A companion study to GS-US-312-0116: To evaluate the effect of Idelalisib on the onset, magnitude, and duration of tumor control.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase 3, Double-Blind Extension Study Evaluating the Efficacy and Safety of Two Different Dose Levels of Single-Agent Idelalisib (GS-1101) as Therapy for Patients With Previously Treated Chronic Lymphocytic Leukemia|
- Overall Response Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Patient Well-Being (Health related quality of life questionnaires) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Disease related biomarkers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Pharmacokinetic [ Time Frame: 6 months ] [ Designated as safety issue: No ]Pharmacokinetic to measure peak plasma concentrations (Cmax) as well as the area under the plasma concentration versus time curve (AUC).
- Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Health Resource Utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: High-dose Idelalisib||
Idelalisib 300mg taken twice daily by mouth
|Active Comparator: Standard-dose Idelalisib||
Idelalisib 150mg taken twice daily by mouth
This study (GS-US-312-0117) is a multicenter, 2-arm, double-blind, parallel-group extension study that is a companion study to Study GS-US-312-0116; in this study, compliant subjects from GS-US-312-0116 who are tolerating primary study therapy but experience chronic lymphocytic leukemia (CLL) progression are eligible to receive active Idelalisib therapy.
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|Study Director:||Thomas Jahn, MD||Gilead Sciences|