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

• Status: Terminated
• Trial end date: 2018-06-18
• Target enrollment: 0
• Participant gender: All

Summary

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 Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Idelalisib

Criteria

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.