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Last Updated: October 21, 2019

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CLINICAL TRIALS PROFILE FOR IDELALISIB

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Clinical Trials for Idelalisib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00836914 Study to Investigate Effects of CAL-101 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber Completed Gilead Sciences Phase 1 2009-02-01 The purpose of this study is to determine the safety and effect of CAL-101 in subjects with allergic rhinitis.
NCT01088048 Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Chron Completed Gilead Sciences Phase 1 2010-04-01 This study will evaluate the safety and clinical activity of idelalisib in combination with an anti-CD20 monoclonal antibody (mAb), a chemotherapeutic agent, an mTOR inhibitor, a protease inhibitor, an antiangiogenic agent, and/or an immunomodulatory agent in participants with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL).
NCT01090414 An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study Active, not recruiting Gilead Sciences Phase 1 2010-03-01 This is a long-term safety extension study of idelalisib (GS-1101; CAL-101) in patients with hematologic malignancies who complete other idelalisib studies. It provides the opportunity for patients to continue treatment as long as the patient is deriving clinical benefit. Patients will be followed according to the standard of care as appropriate for their type of cancer. The dose of idelalisib will generally be the same as the dose that was administered at the end of the prior study, but may be titrated up to improve clinical response or down for toxicity. Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion of the investigator.
NCT01203930 A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL Terminated Gilead Sciences Phase 2 2010-10-01 This study is to evaluate the safety and clinical activity of idelalisib alone and in combination with rituximab in patients with CLL or SLL. This Phase 2 study will be the first time that idelalisib is administered to previously untreated patients with hematologic malignancies. Idelalisib has demonstrated clinical activity as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity, which supports its evaluation in previously untreated patients. The study population is limited to patients over 65 years of age because younger patients are generally appropriate for standard immunochemotherapy regimens that are highly active. Since the mechanism of action of idelalisib is distinct from rituximab, it is hypothesized that the combination will be more active than either agent alone. This study will establish initial safety and clinical activity of idelalisib in combination with rituximab in patients with CLL or SLL. Cohort 2 of this study will establish safety and clinical activity of idelalisib alone in subjects with untreated CLL or SLL.
NCT01282424 Efficacy and Safety Study of Idelalisib in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma Active, not recruiting Gilead Sciences Phase 2 2011-05-01 The purpose of this study is to evaluate the efficacy and safety of idelalisib in patients with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. The primary objective will be to assess the overall response rate. Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant patients as long as the study is still ongoing and the patients appear to be benefiting from treatment with acceptable safety.
NCT01306643 Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma Completed Gilead Sciences Phase 1/Phase 2 2011-02-01 This Phase 1/2, open-label, single-arm, efficacy, safety, and pharmacodynamic study is to evaluate safety and efficacy of idelalisib (GS-1101, CAL-101) in patients with previously treated indolent non-Hodgkin lymphoma (iNHL). 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.
NCT01393106 Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma Completed Gilead Sciences Phase 2 2011-09-01 This study will evaluate the efficacy and safety of idelalisib in participants with relapsed of refractory Hodgkin Lymphoma (HL). The primary objective will be to assess the overall response rate. Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg twice daily. Treatment with idelalisib will continue until tumor progression or unacceptable toxicity.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Idelalisib

Condition Name

Condition Name for Idelalisib
Intervention Trials
Chronic Lymphocytic Leukemia 18
Follicular Lymphoma 9
Small Lymphocytic Lymphoma 8
Marginal Zone Lymphoma 4
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Condition MeSH

Condition MeSH for Idelalisib
Intervention Trials
Leukemia, Lymphocytic, Chronic, B-Cell 31
Leukemia, Lymphoid 28
Leukemia 26
Lymphoma 26
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Clinical Trial Locations for Idelalisib

Trials by Country

Trials by Country for Idelalisib
Location Trials
United States 305
Australia 36
France 32
Canada 23
United Kingdom 23
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Trials by US State

Trials by US State for Idelalisib
Location Trials
New York 26
California 25
Washington 18
Texas 17
Ohio 15
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Clinical Trial Progress for Idelalisib

Clinical Trial Phase

Clinical Trial Phase for Idelalisib
Clinical Trial Phase Trials
Phase 4 1
Phase 3 10
Phase 2 21
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Clinical Trial Status

Clinical Trial Status for Idelalisib
Clinical Trial Phase Trials
Recruiting 18
Not yet recruiting 12
Active, not recruiting 10
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Clinical Trial Sponsors for Idelalisib

Sponsor Name

Sponsor Name for Idelalisib
Sponsor Trials
Gilead Sciences 36
National Cancer Institute (NCI) 5
Dana-Farber Cancer Institute 3
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Sponsor Type

Sponsor Type for Idelalisib
Sponsor Trials
Industry 48
Other 29
NIH 5
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