Roll Over Study to Provide Idelalisib to Participants Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820
This trial is active, not recruiting.
|Start date||May 2016|
|End date||April 2017|
|Trial size||3 participants|
|Trial identifier||NCT02739360, 2015-005766-39, GS-US-313-2120|
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.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Participants will receive idelalisib until unacceptable toxicity, disease progression, study discontinuation, or death occurs.
Safety profile of idelalisib as measured by the incidence of adverse events and serious adverse events
time frame: Up to 1 year
Male or female participants at least 18 years old.
Inclusion Criteria: - Receiving GS-9820 in Study GS-US-315-0102 with objective evidence of clinical benefit - Evidence of a personally signed informed consent 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.
|Official title||An Open Label, Roll Over Study to Provide Idelalisib to Subjects Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820|
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