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Extension Study of Idelalisib in Participants With Chronic Lymphocytic Leukemia (CLL) Who Participated in GS-US-312-0116 (NCT01539512)

NCT01539291 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2019-08-20

Study results available
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Summary

The primary objective of this extension study (GS-US-312-0117) that is a companion study to Study GS-US-312-0116 (NCT01539512), is to evaluate the effect of idelalisib on the onset, magnitude, and duration of tumor control. Randomization was done in study GS-US-312-0116, and carried forward to study GS-US-312-117.

Conditions

Interventions

DRUG

Idelalisib

Idelalisib tablet(s) administered orally twice daily

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-03
Primary Completion
2018-05-21
Completion
2018-06-29
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01539291 on ClinicalTrials.gov