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

Gilead Sciences

Status and phase: Terminated; Phase 4

Conditions: Lymphoid Malignancies

Treatments: Drug: Idelalisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02739360

GS-US-313-2120

2015-005766-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Idelalisib

Experimental group

Description:

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

Treatment:

Drug: Idelalisib