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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02739360
Recruitment Status : Terminated
First Posted : April 15, 2016
Results First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lymphoid Malignancies Drug: Idelalisib Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Roll Over Study to Provide Idelalisib to Subjects Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820
Actual Study Start Date : May 4, 2016
Actual Primary Completion Date : December 28, 2017
Actual Study Completion Date : December 28, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Idelalisib

Arm Intervention/treatment
Experimental: Idelalisib
Participants will receive idelalisib until unacceptable toxicity, disease progression, study discontinuation, or death occurs.
Drug: Idelalisib
Idelalisib 150 mg tablet administered orally twice daily
Other Name: Zydelig®




Primary Outcome Measures :
  1. 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 ]
    The severity of Adverse Events were graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03. An SAE was defined as an event that, at any dose, resulted in one or more of the following: 1) Death, 2) Life-threatening, 3) In-patient hospitalization or prolongation of existing hospitalization, 4) Persistent or significant disability/incapacity, 5) A congenital anomaly/birth defect, or 6) A medically important event or reaction.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739360


Locations
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Netherlands
Amsterdam, Netherlands
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol: Original  [PDF] January 5, 2016
Study Protocol: Amendment 1  [PDF] March 28, 2016
Study Protocol: Amendment 2  [PDF] August 26, 2016
Study Protocol: Amendment 3  [PDF] November 4, 2016
Statistical Analysis Plan  [PDF] March 21, 2018


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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02739360     History of Changes
Other Study ID Numbers: GS-US-313-2120
2015-005766-39 ( EudraCT Number )
First Posted: April 15, 2016    Key Record Dates
Results First Posted: January 16, 2019
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/about/ethics-and-code-of-conduct/policies.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: https://www.gilead.com/about/ethics-and-code-of-conduct/policies

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Idelalisib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action