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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
Not Recruiting
Trial ID: NCT01090414
Purpose
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 Patients will be withdrawn from the study if they develop progressive disease,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.
Official Title
An Extension Study to Investigate the Safety and Durability of Clinical Activity of Idelalisib in Subjects With Hematologic Malignancies
Stanford Investigator(s)
Rondeep Brar
Clinical Associate Professor, Medicine - Hematology
Lauren Maeda
Clinical Associate Professor, Medicine - Oncology
Ash A. Alizadeh, MD/PhD
Moghadam Family Professor
Caroline Berube
Clinical Associate Professor, Medicine - Hematology
Jason Gotlib
Professor of Medicine (Hematology)
Eligibility
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.
Intervention(s):
drug: Idelalisib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061