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

Phase 4

Terminated

• Conditions: Lymphoid Malignancies
• Interventions: Drug: Idelalisib

• Registration Number: NCT02739360
• Lead Sponsor: Gilead Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-15
• Study Start: 2016-05-04
• Primary Completion: 2017-12-28
• Study Completion: 2017-12-28
• Results First Submitted: 2018-12-17
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-15
• Results First Posted: 2019-01-16
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Idelalisib	Idelalisib	Participants will receive idelalisib until unacceptable toxicity, disease progression, study discontinuation, or death occurs.

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths	Up to Day 602 plus 30 days	The severity of Adverse Events were graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03. An SAE was defined as an event that, at any dose, resulted in one or more of the following: 1) Death, 2) Life-threatening, 3) In-patient hospitalization or prolongation of existing hospitalization, 4) Persistent or significant disability/incapacity, 5) A congenital anomaly/birth defect, or 6) A medically important event or reaction.