An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study

Study Overview
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Brief Summary
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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 Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion of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.

Official Title
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An Extension Study to Investigate the Safety and Durability of Clinical Activity of Idelalisib in Subjects With Hematologic Malignancies

Conditions
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Chronic Lymphocytic Leukemia, Lymphoma, Non-Hodgkin

Intervention / Treatment
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* Drug: Idelalisib


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Patients with hematologic malignancies completing a prior idelalisib study with a clinical benefit are eligible Women of childbearing potential must have a negative pregnancy test to be eligible Male patients, and female patients of childbearing potential, must agree to use method(s) of contraception specified in the protocol Key Exclusion Criteria: Patients who are unwilling or unable to comply with the protocol are not eligible Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Idelalisib<br>Participants will receive up to 350 mg of idelalisib twice daily until disease progression or unacceptable toxicity. | Drug: Idelalisib<br>* Idelalisib tablets or capsules administered orally<br>* Other names: CAL-101;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | Overall response rate (ORR) was defined as the percentage of participants who achieve complete response (CR), partial response (PR), or minor response (MR; for lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia (LPL/WM) only). | Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) | 
| Percentage of Participants Who Experienced Any Treatment-Emergent Adverse Events |  | Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) plus 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response | Duration of response (DOR) was defined as the interval from the first documentation of CR, PR, or MR (for LPL/WM) to the earlier of the first documentation of disease progression or death from any cause. DOR was analyzed using Kaplan-Meier (KM) estimates. | Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) | 
| Progression-Free Survival | Progression-free survival (PFS) was defined as the interval from start of idelalisib treatment in the parent study to the earlier of the first documentation of disease progression or death from any cause. PFS was analyzed using KM estimates. | Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) | 
| Overall Survival | Overall survival (OS) was defined as the interval from the start of study treatment in the parent study to death from any cause. OS was analyzed using KM estimates. | Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) | 
| Time to Response | Time to response (TTR) was defined as the interval from start of study treatment to the first documentation of CR, PR, or MR (for LPL/WM). Analysis only includes participants who achieved complete or partial response (or minor response for LPL/WM participants). No participants in the 101-02 (AML and MM) groups achieved a complete or partial response. | Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Idelalisib, Chronic lymphocytic leukemia (CLL), Non-Hodgkin lymphoma (NHL), Phosphatidylinositol 3-kinase (PI3K)