This trial is active, not recruiting.

Conditions chronic lymphocytic leukemia, lymphoma, non-hodgkin
Treatment idelalisib
Phase phase 1
Target PI3K
Sponsor Gilead Sciences
Start date March 2010
End date March 2017
Trial size 202 participants
Trial identifier NCT01090414, 101-99


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 Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Participants will receive up to 300 mg of idelalisib once or twice daily until disease progression or unacceptable toxicity.
idelalisib Zydelig®
Idelalisib tablets administered orally

Primary Outcomes

Overall response rate
time frame: Up to 7 years
Safety as assessed by incidence of grade ≥ 3 adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03
time frame: Up to 7 years

Secondary Outcomes

Duration of Response
time frame: Up to 7 years
Progression-free survival
time frame: Up to 7 years
Overall survival
time frame: Up to 7 years
Time to response
time frame: Up to 7 years

Eligibility Criteria

Male or female participants at least 18 years old.

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 Exclusion Criteria: - Patients who are unwilling or unable to comply with the protocol are not eligible

Additional Information

Official title An Extension Study to Investigate the Safety and Durability of Clinical Activity of Idelalisib in Subjects With Hematologic Malignancies
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Gilead Sciences.
Location data was received from the National Cancer Institute and was last updated in April 2016.