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

Trial ID or NCT#

NCT01090414

Status

not recruiting iconNOT RECRUITING

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 Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - Patients who are unwilling or unable to comply with the protocol are not eligible Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Investigator(s)

Rondeep Brar
Rondeep Brar
Hematologist-Oncologist
Clinical Associate Professor, Medicine - Hematology
Ash A. Alizadeh, MD/PhD
Ash A. Alizadeh, MD/PhD
Medical oncologist, Lymphoma specialist, Cancer geneticist
Moghadam Family Professor
Lauren Maeda
Lauren Maeda
Hematologist, Lymphoma specialist, Hematologist-Oncologist
Clinical Associate Professor, Medicine - Oncology
Caroline Berube
Caroline Berube
Hematologist-Oncologist
Clinical Associate Professor, Medicine - Hematology
Jason Gotlib
Hematologist-Oncologist
Professor of Medicine (Hematology)

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Contact

CCTO
650-498-7061