An Extension Study to Investigate the Safety and Durability of Clinical Activity of CAL-101 in Patients With Hematologic Malignancies
This is a long-term safety extension study of idelilisib (CAL-101, GS-1101) in patients with
hematologic malignancies who complete other CAL-101 studies. Patients will be followed
according to the standard of care as appropriate for their type of cancer. The dose of
idelilisib (CAL-101, GS-1101) 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 may receive other anti-cancer therapy. Patients will be withdrawn
from the study if they develop progressive disease, unacceptable toxicity related to
idelilisib (CAL-101, GS-1101), or if they no longer derive clinical benefit in the opinion
of the investigator.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety
Adverse events will be monitored at routine standard of care visits
Approximately every 3 months
Yes
Thomas Jahn, MD
Study Director
Gilead Sciences
United States: Food and Drug Administration
101-99
NCT01090414
March 2010
December 2013
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Stanford Cancer Center | Stanford, California 94305-5824 |
Oregon Health & Science University | Portland, Oregon 97201 |
UCLA | Los Angeles, California 90095 |
University of Wisconsin | Madison,, Wisconsin 53792-5666 |
Clearview Cancer Institute | Huntsville, Alabama 35805 |
The Ohio State University Medical Center | Columbus, Ohio 43210 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
Weill Medical College of Cornell | New York, New York 10021 |
Willamette Valley Cancer Institute and Research Center | Springfield, Oregon 97477 |
Center for Cancer & Blood Disorders, PC | Bethesda, Maryland 20817 |
MD Anderson Cancer and Research Center | Houston, Texas 77030 |
Yakima Regional Cancer Care | Yakima, Washington 98902 |