An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study
Stopped early · Phase 1/Phase 2
Conditions studied: Chronic Lymphocytic Leukemia, Lymphoma, Non-Hodgkin
In brief
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 Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion of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.
Key facts
- Study ID
- NCT01090414
- Run by
- Gilead Sciences
- People needed
- 202
- Starts
- 2010-03-22
- Expected to finish
- 2018-06-18
- Last updated by the study team
- 2019-08-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Clearview Cancer Institute — Huntsville, Alabama, United States
- UCLA — Los Angeles, California, United States
- Stanford Cancer Center — Palo Alto, California, United States
- Center for Cancer & Blood Disorders, PC — Bethesda, Maryland, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Long Island Jewish medical Center — New Hyde Park, New York, United States
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
- Weill Medical College of Cornell — New York, New York, United States
- Mount Sinai School of Medicine — New York, New York, United States
- The Ohio State University Medical Center — Columbus, Ohio, United States
- Oregon Health & Science University — Portland, Oregon, United States
- Willamette Valley Cancer Institute and Research Center — Springfield, Oregon, United States
- Sarah Cannon Research Institute — Nashville, Tennessee, United States
- MD Anderson Cancer and Research Center — Houston, Texas, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Yakima Regional Cancer Care — Yakima, Washington, United States
- University of Wisconsin — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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