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

August 22, 2019 updated by: Gilead Sciences

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

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 Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Clearview Cancer Institute
    • California
      • Los Angeles, California, United States, 90095-1678
        • UCLA
      • Palo Alto, California, United States, 94304-5548
        • Stanford Cancer Center
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Center for Cancer & Blood Disorders, PC
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New Hyde Park, New York, United States, 11042
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
      • Springfield, Oregon, United States, 97477
        • Willamette Valley Cancer Institute and Research Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer and Research Center
    • Washington
      • Yakima, Washington, United States, 98902
        • Yakima Regional Cancer Care
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-5156
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Idelalisib
Participants will receive up to 350 mg of idelalisib twice daily until disease progression or unacceptable toxicity.
Drug: Idelalisib
Idelalisib tablets or capsules administered orally
Other Names:
  • Zydelig®
  • GS-1101
  • CAL-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)
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
Time Frame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months) plus 30 days
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
Time Frame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)
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
Time Frame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)
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
Time Frame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)
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 Frame: Parent study baseline to end of study 101-99 (maximum: up to 91.2 months)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2010

Primary Completion (Actual)

June 18, 2018

Study Completion (Actual)

June 18, 2018

Study Registration Dates

First Submitted

March 17, 2010

First Submitted That Met QC Criteria

March 18, 2010

First Posted (Estimate)

March 22, 2010

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 22, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101-99

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

IPD Sharing Time Frame

18 months after study completion

IPD Sharing Access Criteria

A secured external environment with username, password, and RSA code.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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