Roll Over Study to Provide Idelalisib to Participants Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820

• Status: Terminated
• Trial end date: 2017-12-28
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Idelalisib

Criteria

Key Inclusion Criteria:

• Receiving GS-9820 in Study GS-US-315-0102 with objective evidence of clinical benefit

• Evidence of a personally signed informed consent

Key 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.

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.