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

NCT02739360 | Terminated Phase 4 Results FDA Drug

• 2 other identifiers: GS-US-313-21202015-005766-39
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoid Malignancies

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths

  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.

  Up to Day 602 plus 30 days

Study Arms (1)

Idelalisib

EXPERIMENTAL

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

Drug: Idelalisib

Interventions

Idelalisib DRUG

Idelalisib 150 mg tablet administered orally twice daily

Also known as: Zydelig®

Idelalisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Unknown Facility

Amsterdam, Netherlands

Location

MeSH Terms

Interventions

idelalisib

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: April 15, 2016
• Study Start: May 4, 2016
• Primary Completion: December 28, 2017
• Study Completion: December 28, 2017
• Last Updated: March 4, 2020
• Results First Posted: January 16, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 18 months after study completion
• Access Criteria: A secured external environment with username, password, and RSA code.

Locations

NL (1)