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

Phase 4TerminatedNCT02739360

Gilead Sciences3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoid Malignancies

Interventions

IdelalisibDRUG

Idelalisib 150 mg tablet administered orally twice daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths

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.

Time frame: Up to Day 602 plus 30 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.