Roll Over Study to Provide Idelalisib to Participants Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820
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|ClinicalTrials.gov Identifier: NCT02739360|
Recruitment Status : Terminated
First Posted : April 15, 2016
Results First Posted : January 16, 2019
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lymphoid Malignancies||Drug: Idelalisib||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Roll Over Study to Provide Idelalisib to Subjects Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820|
|Actual Study Start Date :||May 4, 2016|
|Actual Primary Completion Date :||December 28, 2017|
|Actual Study Completion Date :||December 28, 2017|
Participants will receive idelalisib until unacceptable toxicity, disease progression, study discontinuation, or death occurs.
Idelalisib 150 mg tablet administered orally twice daily
Other Name: Zydelig®
- Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739360
|Study Director:||Gilead Study Director||Gilead Sciences|