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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02739360 |
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Date of registration:
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12/04/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Roll Over Study to Provide Idelalisib to Participants Previously Treated With the Investigational PI3Kd Inhibitor, GS-9820
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Scientific title:
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An Open Label, Roll Over Study to Provide Idelalisib to Subjects Previously Treated With the Investigational PI3Kd Inhibitor, GS-9820 |
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Date of first enrolment:
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May 4, 2016 |
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Target sample size:
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3 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02739360 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Gilead Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gilead Sciences |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lymphoid Malignancies
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Intervention(s)
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Drug: Idelalisib
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Primary Outcome(s)
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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]
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Secondary ID(s)
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2015-005766-39
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GS-US-313-2120
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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