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

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. Identifier: NCT01090414
Recruitment Status : Completed
First Posted : March 22, 2010
Last Update Posted : October 23, 2018
Information provided by (Responsible Party):
Gilead Sciences

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 Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion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

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Lymphoma, Non-Hodgkin Drug: Idelalisib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Study to Investigate the Safety and Durability of Clinical Activity of Idelalisib in Subjects With Hematologic Malignancies
Actual Study Start Date : March 22, 2010
Actual Primary Completion Date : June 18, 2018
Actual Study Completion Date : June 18, 2018

Arm Intervention/treatment
Experimental: Idelalisib
Participants will receive up to 300 mg of idelalisib once or twice daily until disease progression or unacceptable toxicity.
Drug: Idelalisib
Idelalisib tablets administered orally
Other Names:
  • Zydelig®
  • GS-1101
  • CAL-101

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: Up to 7 years ]
    Overall response rate (ORR) is defined as the proportion of participants who achieve complete response (CR), partial response (PR), or minor response (MR; for Waldenström's macroglobulinemia [WM] only).

  2. Safety as assessed by incidence of grade ≥ 3 adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 [ Time Frame: Up to 7 years ]

Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: Up to 7 years ]
    Duration of response (DOR) is defined as the interval from the first documentation of CR, PR, or MR (for WM) to the earlier of the first documentation of definitive disease progression or death from any cause.

  2. Progression-free survival [ Time Frame: Up to 7 years ]
    Progression-free survival (PFS) is defined as the interval from enrollment in the parent study to the earlier of the first documentation of definitive disease progression (excluding lymphocytosis alone) or death from any cause.

  3. Overall survival [ Time Frame: Up to 7 years ]
    Overall survival (OS) is defined as the interval from the start of study treatment in the parent study to death from any cause.

  4. Time to response [ Time Frame: Up to 7 years ]
    Time to response (TTR) is defined as the interval from first dose to the first documentation of CR or PR.

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

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.

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 identifier (NCT number): NCT01090414

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Gilead Sciences Identifier: NCT01090414     History of Changes
Other Study ID Numbers: 101-99
First Posted: March 22, 2010    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: June 2018
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
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
Chronic lymphocytic leukemia (CLL)
Non-Hodgkin lymphoma (NHL)
Phosphatidylinositol 3-kinase (PI3K)

Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action