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Terminated Phase 1Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT01090414

Public ClinicalTrials.gov record NCT01090414. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 6:38 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion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

NCT ID
NCT01090414
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Gilead Sciences
Industry
Enrollment
202 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 21, 2010
Primary completion
Jun 17, 2018
Completion
Jun 17, 2018
Last update posted
Aug 27, 2019

2010 – 2018

United States locations

U.S. sites
18
U.S. states
12
U.S. cities
15
Facility City State ZIP Site status
Clearview Cancer Institute Huntsville Alabama 35805
UCLA Los Angeles California 90095-1678
Stanford Cancer Center Palo Alto California 94304-5548
Center for Cancer & Blood Disorders, PC Bethesda Maryland 20817
Dana-Farber Cancer Institute Boston Massachusetts 02115
Washington University School of Medicine St Louis Missouri 63110
Long Island Jewish medical Center New Hyde Park New York 11042
Memorial Sloan-Kettering Cancer Center New York New York 10021
Weill Medical College of Cornell New York New York 10021
Mount Sinai School of Medicine New York New York 10029
The Ohio State University Medical Center Columbus Ohio 43210
Oregon Health & Science University Portland Oregon 97239
Willamette Valley Cancer Institute and Research Center Springfield Oregon 97477
Sarah Cannon Research Institute Nashville Tennessee 37203
MD Anderson Cancer and Research Center Houston Texas 77030
MD Anderson Cancer Center Houston Texas 77030
Yakima Regional Cancer Care Yakima Washington 98902
University of Wisconsin Madison Wisconsin 53792-5156

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01090414, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 27, 2019 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01090414 live on ClinicalTrials.gov.

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