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

Lymphoid Malignancies Clinical Trial

Official title:

An Open Label, Roll Over Study to Provide Idelalisib to Subjects Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02739360
• Other study ID #: GS-US-313-2120
• Secondary ID: 2015-005766-39
• Status: Terminated
• Phase: Phase 4
• Start date: May 4, 2016
• Est. completion date: December 28, 2017

Study information

• Verified date: January 2019
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 28, 2017
• Est. primary completion date: December 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoid Malignancies
• Neoplasms

Intervention

Drug:
• Idelalisib
Idelalisib 150 mg tablet administered orally twice daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to Day 602 plus 30 days