Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma
NCT ID: NCT01306643
Last Updated: 2018-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
18 participants
INTERVENTIONAL
2011-02-28
2015-08-31
Brief Summary
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Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg twice per day. Treatment with idelalisib can continue in compliant participants for up to twelve 28-day cycles of idelalisib. Participants who appear to be benefiting from treatment at the completion of 12 cycles of treatment with idelalisib may be eligible for participation in a long-term safety extension study of idelalisib.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Idelalisib
Idelalisib
Tablet(s) administered orally twice daily
Interventions
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Idelalisib
Tablet(s) administered orally twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Provide written informed consent
Exclusion Criteria
* Active, serious infection requiring systemic therapy
* Positive test for HIV antibodies
* Active hepatitis B or C viral infection
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Stanford Cancer Center
Palo Alto, California, United States
Mount Sinai School of Medicine
New York, New York, United States
Countries
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Other Identifiers
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101-10
Identifier Type: -
Identifier Source: org_study_id
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