Overview

This trial is active, not recruiting.

Condition lymphoid malignancies
Treatment idelalisib
Phase phase 4
Target PI3K
Sponsor Gilead Sciences
Start date May 2016
End date April 2017
Trial size 3 participants
Trial identifier NCT02739360, 2015-005766-39, GS-US-313-2120

Summary

This study is to provide idelalisib to participants receiving GS-9820 in Gilead-sponsored Study GS-US-315-0102 at the time of study closure.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants will receive idelalisib until unacceptable toxicity, disease progression, study discontinuation, or death occurs.
idelalisib Zydelig®
Idelalisib 150 mg tablet administered orally twice daily

Primary Outcomes

Measure
Safety profile of idelalisib as measured by the incidence of adverse events and serious adverse events
time frame: Up to 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Receiving GS-9820 in Study GS-US-315-0102 with objective evidence of clinical benefit - Evidence of a personally signed informed consent Exclusion Criteria: - Known hypersensitivity or intolerance to any of the active substances or excipients in the formulation of idelalisib - Toxicities that would preclude initiating therapy with idelalisib prior to enrollment - Concurrent participation in another therapeutic clinical trial - Ongoing infection, treatment, or prophylaxis for cytomegalovirus (CMV) within the past 28 days.

Additional Information

Official title An Open Label, Roll Over Study to Provide Idelalisib to Subjects Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.