Overview

This trial is active, not recruiting.

Condition chronic lymphocytic leukemia
Treatment idelalisib
Phase phase 3
Target PI3K
Sponsor Gilead Sciences
Start date October 2012
End date December 2017
Trial size 160 participants
Trial identifier NCT01539291, 2011-006293-72, GS-US-312-0117

Summary

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, to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Participants will receive idelalisib 300 mg twice daily (600 mg per day).
idelalisib Zydelig®
Idelalisib 150 mg tablet(s) administered orally twice daily
(Active Comparator)
Participants will receive idelalisib 150 mg twice daily (300 mg per day)
idelalisib Zydelig®
Idelalisib 150 mg tablet(s) administered orally twice daily

Primary Outcomes

Measure
Overall Safety
time frame: Baseline to Month 12

Secondary Outcomes

Measure
Tumor Control
time frame: Baseline to Month 12
Patient Well-Being
time frame: Baseline to Month 12
Pharmacodynamic
time frame: Baseline to Month 6

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion: - Subjects in the primary Phase 3 study (Study GS-US-312-0116) who are compliant - Tolerating primary study therapy

Additional Information

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) for Previously Treated Chronic Lymphocytic Leukemia
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.