Roll Over Study to Provide Idelalisib to Participants Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-04

Study Completion Date

2017-12-28

Brief Summary

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The primary objective of this study is to provide idelalisib to participants receiving GS-9820 in Gilead-sponsored Study GS-US-315-0102 at the time of study closure.

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Detailed Description

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Conditions

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Lymphoid Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Idelalisib

Participants will receive idelalisib until unacceptable toxicity, disease progression, study discontinuation, or death occurs.

Group Type EXPERIMENTAL

Idelalisib

Intervention Type DRUG

Idelalisib 150 mg tablet administered orally twice daily

Interventions

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Idelalisib

Idelalisib 150 mg tablet administered orally twice daily

Intervention Type DRUG

Other Intervention Names

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Zydelig®

Eligibility Criteria

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Inclusion Criteria

* Receiving GS-9820 in Study GS-US-315-0102 with objective evidence of clinical benefit
* Evidence of a personally signed informed consent

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No